Spinal Pedicle Fixation Orthosis Suppliers
Limit companies to: Worldwide USA
US Spine Inc. | Address: 3600 Fau Blvd., Suite 101, Boca Raton, Florida 33431, USA 
www.us-spine.com | Send Inquiry | Phone: +1-(561)-367-7463
Products: Facet Screw Spinal Device System (FDA Code: MRW), Spinal Interlaminal Fixation Appliance (FDA Code: KWP), Spinal Intervertebral Body Fixation Appliance (FDA Code: KWQ), Spinal Pedicle Fixation Orthosis (FDA Code: MNI), Spinal Vertebral Body Replacement Device (FDA Code: MQP), Spondylolisthesis Spinal Fixation Orthosis (FDA Code: MNH), ...
US Spine Inc. is a medical technology company that designs, develops, manufactures and markets spine implants & instruments. We offer cervical, interbody/VBR, and facet systems, as well as thoracolumb more...
www.us-spine.com | Send Inquiry | Phone: +1-(561)-367-7463
Products: Facet Screw Spinal Device System (FDA Code: MRW), Spinal Interlaminal Fixation Appliance (FDA Code: KWP), Spinal Intervertebral Body Fixation Appliance (FDA Code: KWQ), Spinal Pedicle Fixation Orthosis (FDA Code: MNI), Spinal Vertebral Body Replacement Device (FDA Code: MQP), Spondylolisthesis Spinal Fixation Orthosis (FDA Code: MNH), ...
US Spine Inc. is a medical technology company that designs, develops, manufactures and markets spine implants & instruments. We offer cervical, interbody/VBR, and facet systems, as well as thoracolumb more...
Atlas Spine | Address: 1555 Jupiter Park Dr., Ste. 4, Jupiter, Florida 33458, USA
www.atlasspine.com | Send Inquiry | Phone: +1-(561)-741-1108
FDA Registration: 3003855635
Products: Orthopedic Manual Surgical Instrument (FDA Code: LXH), Spinal Intervertebral Body Fixation Appliance (FDA Code: KWQ), Spinal Pedicle Fixation Orthosis (FDA Code: MNI), Spinal Vertebral Body Replacement Device (FDA Code: MQP), Spondylolisthesis Spinal Fixation Orthosis (FDA Code: MNH), Spinal Pedicle Fixation Orthosis For Degenerative Disc Disease (FDA Code: NKB), ...
Atlas Spine is associated with spinal implants and instrumentation systems. Back-Pak™ discectomy set is our comprehensive set of disc preparation instruments that are designed to provide the sur more...
www.atlasspine.com | Send Inquiry | Phone: +1-(561)-741-1108
FDA Registration: 3003855635
Products: Orthopedic Manual Surgical Instrument (FDA Code: LXH), Spinal Intervertebral Body Fixation Appliance (FDA Code: KWQ), Spinal Pedicle Fixation Orthosis (FDA Code: MNI), Spinal Vertebral Body Replacement Device (FDA Code: MQP), Spondylolisthesis Spinal Fixation Orthosis (FDA Code: MNH), Spinal Pedicle Fixation Orthosis For Degenerative Disc Disease (FDA Code: NKB), ...
Atlas Spine is associated with spinal implants and instrumentation systems. Back-Pak™ discectomy set is our comprehensive set of disc preparation instruments that are designed to provide the sur more...
Eden Spine, Llc | Address: 801 International Parkway, 5th Floor, Lake Mary, Florida 32746, USA
www.edenspine.com | Send Inquiry | Phone: +1-(407)-792 2279
Year Established: 2005 Quality: CE Certified
Products: Disc Replacements, FRS/Fusion and Reconstruction System, Interspinous Process Distraction Device, Spinal Pedicle Fixation Orthosis (FDA Code: MNI), Spondylolisthesis Spinal Fixation Orthosis (FDA Code: MNH), Rna Purification Rna Stabilization Blood Collection Rt-Pcr Molecular Diagnostic Test System (FDA Code: NTW), ...
Eden Spine, Llc provides interspinous process technology called Wellex™ & dynamic posterior stabilization system called Perfx-2™. Our fusion technologies include giza & trade titanium VBR more...
www.edenspine.com | Send Inquiry | Phone: +1-(407)-792 2279
Year Established: 2005 Quality: CE Certified
Products: Disc Replacements, FRS/Fusion and Reconstruction System, Interspinous Process Distraction Device, Spinal Pedicle Fixation Orthosis (FDA Code: MNI), Spondylolisthesis Spinal Fixation Orthosis (FDA Code: MNH), Rna Purification Rna Stabilization Blood Collection Rt-Pcr Molecular Diagnostic Test System (FDA Code: NTW), ...
Eden Spine, Llc provides interspinous process technology called Wellex™ & dynamic posterior stabilization system called Perfx-2™. Our fusion technologies include giza & trade titanium VBR more...
Life Spine | Address: 2401 W. Hassell Rd., Suite 1535, Hoffman Estates, Illinois 60169, USA
www.lifespine.com | Send Inquiry | Phone: +1-(847)-8846117
FDA Registration: 3004499989
Products: Anterior Cervical Plating System, Cement Restrictor Hip Prosthesis (FDA Code: JDK), Facet Screw Spinal Device System (FDA Code: MRW), Orthopedic Manual Surgical Instrument (FDA Code: LXH), Lumbar Intervertebral Fusion Device with Bone Graft (FDA Code: MAX), Lumbar Solid-Sphere Intervertebral Fusion Device With Bone Graft (FDA Code: NVR), ...
Life Spine is a developer, manufacturer and marketer of proprietary medical devices serving the orthopedic and neurosurgery communities. Our cervical products include Neo, Neo-sl, Kinetic and Kinetic- more...
www.lifespine.com | Send Inquiry | Phone: +1-(847)-8846117
FDA Registration: 3004499989
Products: Anterior Cervical Plating System, Cement Restrictor Hip Prosthesis (FDA Code: JDK), Facet Screw Spinal Device System (FDA Code: MRW), Orthopedic Manual Surgical Instrument (FDA Code: LXH), Lumbar Intervertebral Fusion Device with Bone Graft (FDA Code: MAX), Lumbar Solid-Sphere Intervertebral Fusion Device With Bone Graft (FDA Code: NVR), ...
Life Spine is a developer, manufacturer and marketer of proprietary medical devices serving the orthopedic and neurosurgery communities. Our cervical products include Neo, Neo-sl, Kinetic and Kinetic- more...
Spinecraft LLC | Address: 2215 Entreprise Dr., Westchester, Illinois 60154, USA
www.spinecraft.com | Send Inquiry | Phone: +1-(708)-531-9700
FDA Registration: 3004717358
Products: Anterior Cervical Plate, Intersomatic Lumbar Cages, Calcium Compound Bone Void Filler (FDA Code: MQV), Spinal Interlaminal Fixation Appliance (FDA Code: KWP), Osteoinduction Bone Void Filler (FDA Code: MBP), Cervical Intervertebral Fusion Device With Bone Graft (FDA Code: ODP), ...
Spinecraft LLC develops and manufactures spine surgery implants & instrument systems & surgical tools. We provide comprehensive spine care solutions for patients with back pain, neck pain, degenerativ more...
www.spinecraft.com | Send Inquiry | Phone: +1-(708)-531-9700
FDA Registration: 3004717358
Products: Anterior Cervical Plate, Intersomatic Lumbar Cages, Calcium Compound Bone Void Filler (FDA Code: MQV), Spinal Interlaminal Fixation Appliance (FDA Code: KWP), Osteoinduction Bone Void Filler (FDA Code: MBP), Cervical Intervertebral Fusion Device With Bone Graft (FDA Code: ODP), ...
Spinecraft LLC develops and manufactures spine surgery implants & instrument systems & surgical tools. We provide comprehensive spine care solutions for patients with back pain, neck pain, degenerativ more...
Nexxt Spine LLC | Address: 10100 Lantern Rd, Suite 200, Fishers, Indiana 46037, USA
www.nexxtspine.com | Phone: +1-(317)-436-7801
FDA Registration: 3007922509
Products: Anterior Cervical Plate, Pedicle Screw System, Anterior Cervical Plating System, Spinal Pedicle Fixation Orthosis (FDA Code: MNI), Spondylolisthesis Spinal Fixation Orthosis (FDA Code: MNH), Anterior Cervical Plate Systems, ...
Nexxt Spine LLC specializes in spinal implants and instrumentation systems for the surgical market. Our anterior cervical plates are available as 1 level, 2 level , 3 level, 4 level, and 5 level with more...
www.nexxtspine.com | Phone: +1-(317)-436-7801
FDA Registration: 3007922509
Products: Anterior Cervical Plate, Pedicle Screw System, Anterior Cervical Plating System, Spinal Pedicle Fixation Orthosis (FDA Code: MNI), Spondylolisthesis Spinal Fixation Orthosis (FDA Code: MNH), Anterior Cervical Plate Systems, ...
Nexxt Spine LLC specializes in spinal implants and instrumentation systems for the surgical market. Our anterior cervical plates are available as 1 level, 2 level , 3 level, 4 level, and 5 level with more...
Rickman Tool, Inc. | Address: 1202 E. 4th Street, Rochester, Indiana 46975-0547, USA
Phone: +1-(574)-223-8198
Year Established: 1992 Employee Count: ~30
Products: Cement Restrictor Hip Prosthesis (FDA Code: JDK), Spinal Fixation Device Implant (FDA Code: JDN), Spinal Intervertebral Body Fixation Appliance (FDA Code: KWQ), Spinal Pedicle Fixation Orthosis (FDA Code: MNI), Spondylolisthesis Spinal Fixation Orthosis (FDA Code: MNH), Spinal Pedicle Fixation Orthosis For Degenerative Disc Disease (FDA Code: NKB), ...
Rickman Tool, Inc. specializes in spinal orthopedic implants. more...
Phone: +1-(574)-223-8198
Year Established: 1992 Employee Count: ~30
Products: Cement Restrictor Hip Prosthesis (FDA Code: JDK), Spinal Fixation Device Implant (FDA Code: JDN), Spinal Intervertebral Body Fixation Appliance (FDA Code: KWQ), Spinal Pedicle Fixation Orthosis (FDA Code: MNI), Spondylolisthesis Spinal Fixation Orthosis (FDA Code: MNH), Spinal Pedicle Fixation Orthosis For Degenerative Disc Disease (FDA Code: NKB), ...
Rickman Tool, Inc. specializes in spinal orthopedic implants. more...
Orthopediatrics Corp | Address: 210, North Buffalo Street, Warsaw, Indiana 46580, USA
Send Inquiry | Phone: +1-(574)-268-6379/877-268-6339
FDA Registration: 3006460162
Products: Bone Fixation Plate (FDA Code: HRS), Bone Fixation Screw (FDA Code: HWC), Smooth Fixation Pin (FDA Code: HTY), Spinal Interlaminal Fixation Appliance (FDA Code: KWP), Spondylolisthesis Spinal Fixation Orthosis (FDA Code: MNH), Epiphysiodesis Pediatric Growth Control Bone Plate (FDA Code: OBT), ...
Orthopediatrics Corp designs, develops and distributes orthopedic implants for children. Our PediLoc™ femur locked plate system eliminates the need for interoperative bending and contouring. It more...
Send Inquiry | Phone: +1-(574)-268-6379/877-268-6339
FDA Registration: 3006460162
Products: Bone Fixation Plate (FDA Code: HRS), Bone Fixation Screw (FDA Code: HWC), Smooth Fixation Pin (FDA Code: HTY), Spinal Interlaminal Fixation Appliance (FDA Code: KWP), Spondylolisthesis Spinal Fixation Orthosis (FDA Code: MNH), Epiphysiodesis Pediatric Growth Control Bone Plate (FDA Code: OBT), ...
Orthopediatrics Corp designs, develops and distributes orthopedic implants for children. Our PediLoc™ femur locked plate system eliminates the need for interoperative bending and contouring. It more...
Gold Standard Orthopaedics, Llc | Address: 1226 Rowan St, Louisville, Kentucky 40203, USA
www.gsortho.net | Phone: +1-(502)-581-8770
FDA Registration: 3006215390
Products: Spacers, Pedicle Screw System, Hooks, Spinal Interlaminal Fixation Appliance (FDA Code: KWP), Spinal Vertebral Body Replacement Device (FDA Code: MQP), Spondylolisthesis Spinal Fixation Orthosis (FDA Code: MNH), ...
Gold Standard Orthopaedics LIc supplies orthopedic implants. Our products include cross-connector, pedicle and set screws, spacers, multi-axial screw inserter w/ratchet handle, multi-axial screw inser more...
www.gsortho.net | Phone: +1-(502)-581-8770
FDA Registration: 3006215390
Products: Spacers, Pedicle Screw System, Hooks, Spinal Interlaminal Fixation Appliance (FDA Code: KWP), Spinal Vertebral Body Replacement Device (FDA Code: MQP), Spondylolisthesis Spinal Fixation Orthosis (FDA Code: MNH), ...
Gold Standard Orthopaedics LIc supplies orthopedic implants. Our products include cross-connector, pedicle and set screws, spacers, multi-axial screw inserter w/ratchet handle, multi-axial screw inser more...
Spinefrontier, Inc. | Address: 500 Cummings Center, Suite 3500, Beverly, Massachusetts 01915, USA
www.spinefrontier.com | Send Inquiry | Phone: +1-(978)-2323990
FDA Registration: 3005977257
Products: Rehabilitation Aids, Diagnostic Equipment, Instrument for Spine Surgery, Facet Screw Spinal Device System (FDA Code: MRW), Orthopedic Manual Surgical Instrument (FDA Code: LXH), Lumbar Intervertebral Fusion Device with Bone Graft (FDA Code: MAX), ...
Spinefrontier, Inc. provides services for operative instruments, medical devices, diagnostic equipments and rehabilitation aids used in the treatment of spinal diseases. We produce devices and instrum more...
www.spinefrontier.com | Send Inquiry | Phone: +1-(978)-2323990
FDA Registration: 3005977257
Products: Rehabilitation Aids, Diagnostic Equipment, Instrument for Spine Surgery, Facet Screw Spinal Device System (FDA Code: MRW), Orthopedic Manual Surgical Instrument (FDA Code: LXH), Lumbar Intervertebral Fusion Device with Bone Graft (FDA Code: MAX), ...
Spinefrontier, Inc. provides services for operative instruments, medical devices, diagnostic equipments and rehabilitation aids used in the treatment of spinal diseases. We produce devices and instrum more...
Lab Medical Manufacturing, Inc. | Address: 28 Cook Street, Billerica, Massachusetts 01821, USA
Phone: +1-(978)-6632475-202
FDA Registration: 1223421
Products: Spinal Interlaminal Fixation Appliance (FDA Code: KWP), Spinal Pedicle Fixation Orthosis (FDA Code: MNI), Spondylolisthesis Spinal Fixation Orthosis (FDA Code: MNH), ...
Lab Medical Manufacturing, Inc. provides spinal interlaminal fixation appliance, spinal pedicle and spondylolisthesis spinal fixation orthosis. more...
Phone: +1-(978)-6632475-202
FDA Registration: 1223421
Products: Spinal Interlaminal Fixation Appliance (FDA Code: KWP), Spinal Pedicle Fixation Orthosis (FDA Code: MNI), Spondylolisthesis Spinal Fixation Orthosis (FDA Code: MNH), ...
Lab Medical Manufacturing, Inc. provides spinal interlaminal fixation appliance, spinal pedicle and spondylolisthesis spinal fixation orthosis. more...
Biotechni America Spine Group, Inc. | Address: 28r Cook Street, Billerica, Massachusetts 01821, USA
Phone: +1-(617)-308-4500
Products: Spinal Intervertebral Body Fixation Appliance (FDA Code: KWQ), Spinal Pedicle Fixation Orthosis (FDA Code: MNI), Spondylolisthesis Spinal Fixation Orthosis (FDA Code: MNH), ...
Biotechni America Spine Group, Inc. deals with spinal fixation products. Our products include spinal intervertebral body fixation appliances, spinal pedicle fixation orthosis and spondylolisthesis spi more...
Phone: +1-(617)-308-4500
Products: Spinal Intervertebral Body Fixation Appliance (FDA Code: KWQ), Spinal Pedicle Fixation Orthosis (FDA Code: MNI), Spondylolisthesis Spinal Fixation Orthosis (FDA Code: MNH), ...
Biotechni America Spine Group, Inc. deals with spinal fixation products. Our products include spinal intervertebral body fixation appliances, spinal pedicle fixation orthosis and spondylolisthesis spi more...
Symmetry Medical Inc. | Address: New Bedford Industrial Park, New Bedford, Massachusetts 02745, USA
www.symmetrymedical.com | Phone: +1-(508)-998-4493
Products: Calipers, Flexible Osteotome System, Bone Tamp, Orthopedic Caliper, Reamer (FDA Code: HTO), Screw Removal Systems, ...
Symmetry Medical Inc. manufactures implants, instruments and cases to orthopedic devices. We offer cases and trays that made of metal, plastic or hybrid. We provide forged, cast, machined and finished more...
www.symmetrymedical.com | Phone: +1-(508)-998-4493
Products: Calipers, Flexible Osteotome System, Bone Tamp, Orthopedic Caliper, Reamer (FDA Code: HTO), Screw Removal Systems, ...
Symmetry Medical Inc. manufactures implants, instruments and cases to orthopedic devices. We offer cases and trays that made of metal, plastic or hybrid. We provide forged, cast, machined and finished more...
Pioneer Surgical Technology | Address: 375 River Park Circle, Marquette, Michigan 49855, USA
www.pioneersurgical.com | Send Inquiry | Phone: +1-(906)-226-9909, 800-557-9909
FDA Registration: 1833824 Year Established: 1992 Annual Revenues: USD 25-50 Million Employee Count: ~140 Quality: ISO 9001, CE Certified
Products: Modular Sternal Cable System, Anterior Cervical Plating System, Surgical Instrument Tray (FDA Code: FSM), Electrosurgical Cutting and Coagulation Device (FDA Code: GEI), Bone Fixation Screw (FDA Code: HWC), Spinal Fixation Device Implant (FDA Code: JDN), ...
Pioneer Surgical Technology deals with the design and manufacture of spinal & orthopedic implants & instruments. Our Quantum® spinal rod system comes with polyaxial & fixed pedicle screws, straigh more...
www.pioneersurgical.com | Send Inquiry | Phone: +1-(906)-226-9909, 800-557-9909
FDA Registration: 1833824 Year Established: 1992 Annual Revenues: USD 25-50 Million Employee Count: ~140 Quality: ISO 9001, CE Certified
Products: Modular Sternal Cable System, Anterior Cervical Plating System, Surgical Instrument Tray (FDA Code: FSM), Electrosurgical Cutting and Coagulation Device (FDA Code: GEI), Bone Fixation Screw (FDA Code: HWC), Spinal Fixation Device Implant (FDA Code: JDN), ...
Pioneer Surgical Technology deals with the design and manufacture of spinal & orthopedic implants & instruments. Our Quantum® spinal rod system comes with polyaxial & fixed pedicle screws, straigh more...
Spinal Usa Llc | Address: 2050 Executive Dr, Pearl, Mississippi 39208, USA
www.spinalusa.com | Send Inquiry | Phone: +1-(601)-4204244
FDA Registration: 3005739886 Year Established: 2005 Quality: ISO 13485 Certified
Products: Pedicle Screw System, Anterior Cervical Plating System, Cement Restrictor Hip Prosthesis (FDA Code: JDK), Spinal Intervertebral Body Fixation Appliance (FDA Code: KWQ), Spinal Pedicle Fixation Orthosis (FDA Code: MNI), Spondylolisthesis Spinal Fixation Orthosis (FDA Code: MNH), ...
Spinal Usa Llc. manufactures and distributes spinal products. Our product line offers surgeons enhanced intraoperative flexibility, simplified surgical technique and superior instrumentation. Our prod more...
www.spinalusa.com | Send Inquiry | Phone: +1-(601)-4204244
FDA Registration: 3005739886 Year Established: 2005 Quality: ISO 13485 Certified
Products: Pedicle Screw System, Anterior Cervical Plating System, Cement Restrictor Hip Prosthesis (FDA Code: JDK), Spinal Intervertebral Body Fixation Appliance (FDA Code: KWQ), Spinal Pedicle Fixation Orthosis (FDA Code: MNI), Spondylolisthesis Spinal Fixation Orthosis (FDA Code: MNH), ...
Spinal Usa Llc. manufactures and distributes spinal products. Our product line offers surgeons enhanced intraoperative flexibility, simplified surgical technique and superior instrumentation. Our prod more...
Ulrich Medical. | Address: 54 Spirit 40 Park Drive, Chesterfield, Missouri 63005, USA
www.ulrichmedical.com | Send Inquiry | Phone: +1-(866)-519-0268
FDA Registration: 9612420
Products: Forceps (FDA Code: HTD), Ankle Distractors, General Surgical Instruments, Packaging, Spinal Implants, Medical Diagnostic Imaging, ...
Ulrich Medical specializes in providing spiral implants, tourniquets, surgical instruments and family of cages products. Our Cosmic™ system provides stabilized suspension of the spinal segments a more...
www.ulrichmedical.com | Send Inquiry | Phone: +1-(866)-519-0268
FDA Registration: 9612420
Products: Forceps (FDA Code: HTD), Ankle Distractors, General Surgical Instruments, Packaging, Spinal Implants, Medical Diagnostic Imaging, ...
Ulrich Medical specializes in providing spiral implants, tourniquets, surgical instruments and family of cages products. Our Cosmic™ system provides stabilized suspension of the spinal segments a more...
Atpac Medical LLC | Address: 631 N Stephanie St, Ste 548, Henderson, Nevada 89014, USA
Products: Spinal Pedicle Fixation Orthosis (FDA Code: MNI), Spondylolisthesis Spinal Fixation Orthosis (FDA Code: MNH), ...
Atpac Medical LLC specializes in spinal fixation orthosis. more...
Products: Spinal Pedicle Fixation Orthosis (FDA Code: MNI), Spondylolisthesis Spinal Fixation Orthosis (FDA Code: MNH), ...
Atpac Medical LLC specializes in spinal fixation orthosis. more...
Cardo Medical, Llc | Address: 10 Clifton Blvd., Suite B1, Clifton, New Jersey 07011, USA
www.cardomedical.com | Send Inquiry | Phone: +1-(973)-777-8832
Products: Instruments for Total Hip Surgery, Femoral Elevator for Total Hip Resurfacing, Bone Fixation Screw (FDA Code: HWC), Femoral Hemi- Knee Prosthesis (FDA Code: HSA), Metal/Polymer Femoral Hemi- Hip Prosthesis (FDA Code: KWY), Knee Joint Femorotibial Metal/Polymer Non-constrained Cemented Prosthesis (FDA Code: HSX), ...
Cardo Medical manufactures reconstructive orthopedic and spinal surgery products. Align 360® uni-compartmental knee system allows the surgeon discretion in treating stages of degenerative knee con more...
www.cardomedical.com | Send Inquiry | Phone: +1-(973)-777-8832
Products: Instruments for Total Hip Surgery, Femoral Elevator for Total Hip Resurfacing, Bone Fixation Screw (FDA Code: HWC), Femoral Hemi- Knee Prosthesis (FDA Code: HSA), Metal/Polymer Femoral Hemi- Hip Prosthesis (FDA Code: KWY), Knee Joint Femorotibial Metal/Polymer Non-constrained Cemented Prosthesis (FDA Code: HSX), ...
Cardo Medical manufactures reconstructive orthopedic and spinal surgery products. Align 360® uni-compartmental knee system allows the surgeon discretion in treating stages of degenerative knee con more...
Custom Spine, Inc. | Address: 1140 Parsippany Blvd., Suite 201, Parsippany, New Jersey 07054, USA
www.customspine.com | Send Inquiry | Phone: +1-(973)-808-0019
Products: Spinal Implants, Anterior Cervical Plate, Cervical Plate System, Spinal Intervertebral Body Fixation Appliance (FDA Code: KWQ), Lumbar Intervertebral Fusion Device with Bone Graft (FDA Code: MAX), Spinal Vertebral Body Replacement Device (FDA Code: MQP), ...
Custom Spine, Inc. develops spinal implants and instrumentations. We focus on the cause of chronic pain in the cervical region which includes cervical disc herniations and stenosis as well as spondylo more...
www.customspine.com | Send Inquiry | Phone: +1-(973)-808-0019
Products: Spinal Implants, Anterior Cervical Plate, Cervical Plate System, Spinal Intervertebral Body Fixation Appliance (FDA Code: KWQ), Lumbar Intervertebral Fusion Device with Bone Graft (FDA Code: MAX), Spinal Vertebral Body Replacement Device (FDA Code: MQP), ...
Custom Spine, Inc. develops spinal implants and instrumentations. We focus on the cause of chronic pain in the cervical region which includes cervical disc herniations and stenosis as well as spondylo more...
Synthes (USA) | Address: 35 Airport Road, Horseheads, New York 14845, USA
www.synthes.com/html | Send Inquiry | Phone: +1-(610)-719-5000
FDA Registration: 3003506883 Year Established: 1974 Annual Revenues: > USD 1 Billion Employee Count: ~9000
Products: Bone Taps (FDA Code: HWX), Stainless Steel Surgical Wire, Drill Bits & Bone Taps, Surgical Wire (FDA Code: LRN), Burr Hole Cover (FDA Code: GXR), Bone Fixation Plate (FDA Code: HRS), ...
Synthes (USA) is a medical device company. We develop, produce and market instruments, implants & biomaterials for the surgical fixation, correction and regeneration of the human skeleton & its soft t more...
www.synthes.com/html | Send Inquiry | Phone: +1-(610)-719-5000
FDA Registration: 3003506883 Year Established: 1974 Annual Revenues: > USD 1 Billion Employee Count: ~9000
Products: Bone Taps (FDA Code: HWX), Stainless Steel Surgical Wire, Drill Bits & Bone Taps, Surgical Wire (FDA Code: LRN), Burr Hole Cover (FDA Code: GXR), Bone Fixation Plate (FDA Code: HRS), ...
Synthes (USA) is a medical device company. We develop, produce and market instruments, implants & biomaterials for the surgical fixation, correction and regeneration of the human skeleton & its soft t more...
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FDA Code / Regulation: MNI / 888.3070
Pedicle screw spinal systems are multiple component devices, made from a variety of materials, including alloys such as 316L stainless steel, 316LVM stainless steel, 22Cr-13Ni-5Mn stainless steel, Ti-6Al-4V, and unalloyed titanium, that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of anchors (e.g., bolts, hooks, and/or screws); interconnection mechanisms incorporating nuts, screws, sleeves, or bolts; longitudinal members (e.g., plates, rods, and/or plate/rod combinations); and/or transverse connectors.
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:
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