Spinal Pedicle Fixation Orthosis For Degenerative Disc Disease Suppliers
Limit companies to: Worldwide USA
Nuvasive Inc. | Address: 4545, Towne Centre Court, San Diego, California 92121, USA 
www.nuvasive.com | Send Inquiry | Phone: +1-(800)-455-1476
FDA Registration: 2031966 Year Established: 1997
Products: Facet Screws, Translaminar Facet Screws, Transarticular Facet Screws, Bilateral Facet Screws, Evaluated Facet Screws, Posterior Cervical Plating Systems, ...
Nuvasive Inc. focuses on the design, development and marketing of products for the surgical treatment of spinal disorders. We provide safe & reproductive procedural solutions with platform technology more...
www.nuvasive.com | Send Inquiry | Phone: +1-(800)-455-1476
FDA Registration: 2031966 Year Established: 1997
Products: Facet Screws, Translaminar Facet Screws, Transarticular Facet Screws, Bilateral Facet Screws, Evaluated Facet Screws, Posterior Cervical Plating Systems, ...
Nuvasive Inc. focuses on the design, development and marketing of products for the surgical treatment of spinal disorders. We provide safe & reproductive procedural solutions with platform technology more...
Medtronic Xomed Surgical Products, Inc | Address: 6743 Southpoint Drive North, Jacksonville, Florida 32216-0980, USA
www.xomed.com | Phone: +1-(904)-296-9600, 800-874-5797
FDA Registration: 1045254 Year Established: 1999 Annual Revenues: USD 500 Million to 1 Billion Employee Count: ~650 Quality: ISO 9001, CE Certified
Products: Sinus Trochars and Cannulae, Surgical Navigation Interface/Display, Nerve Stimulators, Eyeshields, General Diagnostic Supplies, General Surgical Aids, ...
Medtronic Xomed Surgical Products, Inc develops products that treat people with ear, nose and throat (ENT) diseases. our products include MeroPack®, Bioresorbable Nasal Dressing and Sinus Stent, I more...
www.xomed.com | Phone: +1-(904)-296-9600, 800-874-5797
FDA Registration: 1045254 Year Established: 1999 Annual Revenues: USD 500 Million to 1 Billion Employee Count: ~650 Quality: ISO 9001, CE Certified
Products: Sinus Trochars and Cannulae, Surgical Navigation Interface/Display, Nerve Stimulators, Eyeshields, General Diagnostic Supplies, General Surgical Aids, ...
Medtronic Xomed Surgical Products, Inc develops products that treat people with ear, nose and throat (ENT) diseases. our products include MeroPack®, Bioresorbable Nasal Dressing and Sinus Stent, I more...
Biomet, Inc | Address: PO Box 587, Warsaw, Indiana 46581-0587, USA
www.biomet.com/orthopedics | Send Inquiry | Phone: +1-(574)-267-6639
FDA Registration: 1825034 Year Established: 1977 Annual Revenues: > USD 1 Billion Employee Count: ~20 Quality: ISO 9001, CE Certified
Products: Drills, Drills Accessories, High Speed Orthopedic Drills, Surgical Drills, Orbital Procedures, Bone Drills, Orthopedics, High Speed Drills System, ...
Biomet, Inc designs and manufactures products for hip replacement, knee replacement, shoulder replacement, elbow replacement & other small joint replacements. We are an ISO 9001 CE certified company. more...
www.biomet.com/orthopedics | Send Inquiry | Phone: +1-(574)-267-6639
FDA Registration: 1825034 Year Established: 1977 Annual Revenues: > USD 1 Billion Employee Count: ~20 Quality: ISO 9001, CE Certified
Products: Drills, Drills Accessories, High Speed Orthopedic Drills, Surgical Drills, Orbital Procedures, Bone Drills, Orthopedics, High Speed Drills System, ...
Biomet, Inc designs and manufactures products for hip replacement, knee replacement, shoulder replacement, elbow replacement & other small joint replacements. We are an ISO 9001 CE certified company. more...
Luxtec | Address: 99 Hartwell Street, West Boylston, Maryland 01583, USA
www.luxtec.com | Send Inquiry | Phone: +1-(508)-835-9700
Year Established: 1981 Annual Revenues: USD 10-25 Million Employee Count: ~140 Quality: ISO 9001, CE Certified
Products: Light Sources, Surgical Headlights, Recording Systems, Headlight Box / Light source, Digital Video Recorders, Recording Devices, ...
Luxtec produces medical illumination systems. We develop lighting and visualization systems for the operating room. Our products include headlights, ultralite, halogen, camera, surgical loupes, monito more...
www.luxtec.com | Send Inquiry | Phone: +1-(508)-835-9700
Year Established: 1981 Annual Revenues: USD 10-25 Million Employee Count: ~140 Quality: ISO 9001, CE Certified
Products: Light Sources, Surgical Headlights, Recording Systems, Headlight Box / Light source, Digital Video Recorders, Recording Devices, ...
Luxtec produces medical illumination systems. We develop lighting and visualization systems for the operating room. Our products include headlights, ultralite, halogen, camera, surgical loupes, monito more...
Depuy Spine, Inc. | Address: 325 Paramount Drive, Raynham, Massachusetts 02767, USA
www.depuyacromed.com | Send Inquiry | Phone: +1-(508)-880-8100
FDA Registration: 1526439 Year Established: 1895
Products: Allografts, Anterior, Anterior Cruciate Ligament Surgical Reconstruction System, Anterior Cervical Plate, Anterior Lumbar Plate System, AC-Powered Surgical Instrument Motor (FDA Code: GEY), ...
Depuy Spine, Inc. designs, manufactures and sells orthopaedic devices & supplies. Our Devex™ System is indicated for use in the thoracolumbar spine to replace a diseased vertebral body resected more...
www.depuyacromed.com | Send Inquiry | Phone: +1-(508)-880-8100
FDA Registration: 1526439 Year Established: 1895
Products: Allografts, Anterior, Anterior Cruciate Ligament Surgical Reconstruction System, Anterior Cervical Plate, Anterior Lumbar Plate System, AC-Powered Surgical Instrument Motor (FDA Code: GEY), ...
Depuy Spine, Inc. designs, manufactures and sells orthopaedic devices & supplies. Our Devex™ System is indicated for use in the thoracolumbar spine to replace a diseased vertebral body resected more...
Blackstone Medical, Inc. | Address: 90 Brookdale Drive, Springfield, Massachusetts 01104, USA
www.blackstonemedical.com | Send Inquiry | Phone: +1-(413)-731-8711
Annual Revenues: USD 10-25 Million Employee Count: ~20 Quality: CE Certified
Products: Arthroscopes (FDA Code: HRX), Bio Absorbable Plating Systems, Bone Mallets (FDA Code: HXL), Anterior Old Plating Systems, Awl (FDA Code: HWJ), Bender (FDA Code: HXW), ...
Blackstone Medical Inc. produces surgical instruments and devices used in back surgery. Our ascent poct system provides surgeons with means to address complicated fusion cases from the base of the sku more...
www.blackstonemedical.com | Send Inquiry | Phone: +1-(413)-731-8711
Annual Revenues: USD 10-25 Million Employee Count: ~20 Quality: CE Certified
Products: Arthroscopes (FDA Code: HRX), Bio Absorbable Plating Systems, Bone Mallets (FDA Code: HXL), Anterior Old Plating Systems, Awl (FDA Code: HWJ), Bender (FDA Code: HXW), ...
Blackstone Medical Inc. produces surgical instruments and devices used in back surgery. Our ascent poct system provides surgeons with means to address complicated fusion cases from the base of the sku more...
Globus Medical, Inc. | Address: 2560 General Armistead Avenue, Audubon, Pennsylvania 19403, USA
www.globusmedical.com | Send Inquiry | Phone: +1-(610)-415-9000
FDA Registration: 3004142400
Products: Plating Systems, Spinal Plates, Anterior Cervical Fusion Kit, Spinal Products, Anterior Cervical Plate, Cervical Plate System, ...
Globus Medical, Inc. offers a complete suite of spinal products including fusion, MIS (minimally invasive surgery), motion preservation and biomaterials. Our portfolio includes a full line of technolo more...
www.globusmedical.com | Send Inquiry | Phone: +1-(610)-415-9000
FDA Registration: 3004142400
Products: Plating Systems, Spinal Plates, Anterior Cervical Fusion Kit, Spinal Products, Anterior Cervical Plate, Cervical Plate System, ...
Globus Medical, Inc. offers a complete suite of spinal products including fusion, MIS (minimally invasive surgery), motion preservation and biomaterials. Our portfolio includes a full line of technolo more...
Orthofix Inc. | Address: 1720 Bray Central Drive, McKinney, Texas 75069, USA
www.orthofix.com | Send Inquiry | Phone: +1-(469)-742-2500, 800-535-4492
FDA Registration: 2183449 Year Established: 1980 Employee Count: ~200 Quality: ISO Certified
Products: Proximal Femoral & Recon Nails, Spinal Orthoses, Bone Screws, Compression Distraction, Clicker, Counter Nuts, Threaded Bars, ...
Orthofix Inc. designs, manufactures & distributes medical equipment, mainly for the orthopedic market. Our orthopedics, spine and sports medicine divisions offer innovative treatment options for adult more...
www.orthofix.com | Send Inquiry | Phone: +1-(469)-742-2500, 800-535-4492
FDA Registration: 2183449 Year Established: 1980 Employee Count: ~200 Quality: ISO Certified
Products: Proximal Femoral & Recon Nails, Spinal Orthoses, Bone Screws, Compression Distraction, Clicker, Counter Nuts, Threaded Bars, ...
Orthofix Inc. designs, manufactures & distributes medical equipment, mainly for the orthopedic market. Our orthopedics, spine and sports medicine divisions offer innovative treatment options for adult more...
EBI Patient Care, Inc. | Address: 1 Electro-biology Blvd., Guaynabo 00657, USA
Phone: +1-(973)-299-9300
FDA Registration: 3003435252
Products: Bone Taps (FDA Code: HWX), Arm Slings (FDA Code: ILI), Abdominal Binders (FDA Code: FSD), Bone Fixation Plate (FDA Code: HRS), Bone Fixation Screw (FDA Code: HWC), Cast Bandage (FDA Code: ITG), ...
EBI Patient Care, Inc. provides braces thermal therapy devices, spinal endoscopic system and cast bandage. more...
Phone: +1-(973)-299-9300
FDA Registration: 3003435252
Products: Bone Taps (FDA Code: HWX), Arm Slings (FDA Code: ILI), Abdominal Binders (FDA Code: FSD), Bone Fixation Plate (FDA Code: HRS), Bone Fixation Screw (FDA Code: HWC), Cast Bandage (FDA Code: ITG), ...
EBI Patient Care, Inc. provides braces thermal therapy devices, spinal endoscopic system and cast bandage. more...
Alphatec Spine, Inc. | Address: 5818 El Camino Real, Carlsbad, California 92008, USA
www.alphatecspine.com | Send Inquiry | Phone: +1-(760)-431-9286, 800-922-1356
FDA Registration: 2027467
Products: Anterior Cervical Plating System, Disposable Aspiration and Injection Needle (FDA Code: GAA), Bone Fixation Nail (FDA Code: JDS), Bone Fixation Plate (FDA Code: HRS), Bone Fixation Screw (FDA Code: HWC), Cervical Intervertebral Fusion Device With Bone Graft (FDA Code: ODP), ...
Alphatec Spine, Inc. is a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spine disorders, primarily focused on the aging spine. We have more...
www.alphatecspine.com | Send Inquiry | Phone: +1-(760)-431-9286, 800-922-1356
FDA Registration: 2027467
Products: Anterior Cervical Plating System, Disposable Aspiration and Injection Needle (FDA Code: GAA), Bone Fixation Nail (FDA Code: JDS), Bone Fixation Plate (FDA Code: HRS), Bone Fixation Screw (FDA Code: HWC), Cervical Intervertebral Fusion Device With Bone Graft (FDA Code: ODP), ...
Alphatec Spine, Inc. is a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spine disorders, primarily focused on the aging spine. We have more...
Zimmer Dental, Inc. | Address: 1900 Aston Ave., Carlsbad, California 92008, USA
www.zimmerdental.com | Phone: +1-(760)-929-4300, 800-854-7019
FDA Registration: 2023141 Year Established: 1927 Annual Revenues: USD 100-500 Million Employee Count: ~410 Quality: ISO 13485, CE Certified
Products: Synthetic Bone Graft Substitute Granules, Bone Graft Substitute Plugs, Bone Graft Substitute Blocks, Bone Graft Substitute Osteotomy Wedges, Bone Graft Harvester, Allograft Bone Graft, ...
Zimmer Dental, Inc. specializes in dental implant products. Our product portfolio comprises of root-form endosseous dental implants, prosthetic attachments for restoration, surgical instrumentation, c more...
www.zimmerdental.com | Phone: +1-(760)-929-4300, 800-854-7019
FDA Registration: 2023141 Year Established: 1927 Annual Revenues: USD 100-500 Million Employee Count: ~410 Quality: ISO 13485, CE Certified
Products: Synthetic Bone Graft Substitute Granules, Bone Graft Substitute Plugs, Bone Graft Substitute Blocks, Bone Graft Substitute Osteotomy Wedges, Bone Graft Harvester, Allograft Bone Graft, ...
Zimmer Dental, Inc. specializes in dental implant products. Our product portfolio comprises of root-form endosseous dental implants, prosthetic attachments for restoration, surgical instrumentation, c more...
Spinal Elements, Inc. | Address: 2744 Loker Ave. W. Suite 100, Carlsbad, California 92010, USA
www.spinalelements.com | Send Inquiry | Phone: +1-(760)-607-0121
FDA Registration: 3004893332
Products: Mallets, Osteotomes, Fixation Pins, Lamina Spreader, Nerve Retractor, Myringotomy Tube Inserter (FDA Code: JYM), ...
Spinal Elements, Inc. deals with orthopedic products. We specialize in motion preservation and spinal fusion. Our Mosaic™ cervical implant system has a radiolucent material design that improves more...
www.spinalelements.com | Send Inquiry | Phone: +1-(760)-607-0121
FDA Registration: 3004893332
Products: Mallets, Osteotomes, Fixation Pins, Lamina Spreader, Nerve Retractor, Myringotomy Tube Inserter (FDA Code: JYM), ...
Spinal Elements, Inc. deals with orthopedic products. We specialize in motion preservation and spinal fusion. Our Mosaic™ cervical implant system has a radiolucent material design that improves more...
Hoosier, Inc. | Address: 1152 California Ave., Corona, California 92881, USA
www.hoosierinc.com | Phone: +1-(951)-272-3070
FDA Registration: 2032093 Quality: ISO 9001:2000 and ISO 13485 Certified
Products: Knee Systems, Drill Guides, Compression Screw, Pedicle Screw System, Pedicle Screws, Partial Knee Systems, ...
Hoosier, Inc. specializes in surgical tools, implants, and medical diagnostics. With 3rd, 4th, and 5th axis machining, we offer a wide range of machining applications & complexity. We are specialized more...
www.hoosierinc.com | Phone: +1-(951)-272-3070
FDA Registration: 2032093 Quality: ISO 9001:2000 and ISO 13485 Certified
Products: Knee Systems, Drill Guides, Compression Screw, Pedicle Screw System, Pedicle Screws, Partial Knee Systems, ...
Hoosier, Inc. specializes in surgical tools, implants, and medical diagnostics. With 3rd, 4th, and 5th axis machining, we offer a wide range of machining applications & complexity. We are specialized more...
Allez Spine, LLC | Address: 2301 Dupont Drive, Suite 510, Irvine, California 92612, USA
www.allezspine.com | Send Inquiry | Phone: +1-(949)-752-7885, 800-939-7008
FDA Registration: 3005032381
Products: Pedicle Screws, Spinal Interlaminal Fixation Appliance (FDA Code: KWP), 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), ...
Allez Spine, LLC designs, manufactures and distributes spinal fusion systems. We produce prototype products and customized instrumentation to meet the needs of spine surgeons. We provide Laguna® p more...
www.allezspine.com | Send Inquiry | Phone: +1-(949)-752-7885, 800-939-7008
FDA Registration: 3005032381
Products: Pedicle Screws, Spinal Interlaminal Fixation Appliance (FDA Code: KWP), 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), ...
Allez Spine, LLC designs, manufactures and distributes spinal fusion systems. We produce prototype products and customized instrumentation to meet the needs of spine surgeons. We provide Laguna® p more...
Vertiflex Incorporated | Address: 1351 Calle Avanzado, San Clemente, California 92673, USA
Phone: +1-(949)-940-1434
FDA Registration: 3005882106
Products: Medical Devices, 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), ...
Vertiflex Incorporated is a medical device company. more...
Phone: +1-(949)-940-1434
FDA Registration: 3005882106
Products: Medical Devices, 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), ...
Vertiflex Incorporated is a medical device company. more...
Seaspine | Address: 2302 La Mirada Drive, Vista, California 92081-7862, USA
www.seaspine.com | Send Inquiry | Phone: +1-(760)-727-8399
Year Established: 2002 Annual Revenues: USD 10-25 Million Employee Count: ~20
Products: Anterior Cervical Plate, Bone Graft Harvester, General use Surgical Curettes (FDA Code: FZS), Manual Surgical Chisel (FDA Code: FZO), Lumbar Intervertebral Fusion Device with Bone Graft (FDA Code: MAX), Cervical Intervertebral Fusion Device With Bone Graft (FDA Code: ODP), ...
Seaspine provides medical products for the spine fusion market. Our Cardiff™ anterior cervical plate system has a low profile design. This system has large windows for viewing the disc space and more...
www.seaspine.com | Send Inquiry | Phone: +1-(760)-727-8399
Year Established: 2002 Annual Revenues: USD 10-25 Million Employee Count: ~20
Products: Anterior Cervical Plate, Bone Graft Harvester, General use Surgical Curettes (FDA Code: FZS), Manual Surgical Chisel (FDA Code: FZO), Lumbar Intervertebral Fusion Device with Bone Graft (FDA Code: MAX), Cervical Intervertebral Fusion Device With Bone Graft (FDA Code: ODP), ...
Seaspine provides medical products for the spine fusion market. Our Cardiff™ anterior cervical plate system has a low profile design. This system has large windows for viewing the disc space and more...
Lanx, Inc | Address: 390 Interlocken Crescent, Suite 890, Broomfield, Colorado 80021, USA
Phone: +1-(303)-4437500
Products: Orthopedic Manual Surgical Instrument (FDA Code: LXH), Spinal Interlaminal Fixation Appliance (FDA Code: KWP), 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), ...
Lanx, Inc offers orthopedic manual surgical instruments, spinal interlaminal fixation appliances and spinal pedicle fixation orthosis. more...
Phone: +1-(303)-4437500
Products: Orthopedic Manual Surgical Instrument (FDA Code: LXH), Spinal Interlaminal Fixation Appliance (FDA Code: KWP), 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), ...
Lanx, Inc offers orthopedic manual surgical instruments, spinal interlaminal fixation appliances and spinal pedicle fixation orthosis. more...
Tomz Corp. | Address: 47 Episcopal Rd., Berlin, Connecticut 06037, USA
www.tomz.com | Send Inquiry | Phone: +1-(860)-829-0670
Products: General Surgical Manual Instrument (FDA Code: MDM), Spinal Interlaminal Fixation Appliance (FDA Code: KWP), 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), ...
Tomz Corp. specializes in providing surgical instrumentation and implants. Our medical tooling, implants and components are made of titanium, cobalt, stainless steel and aluminum. more...
www.tomz.com | Send Inquiry | Phone: +1-(860)-829-0670
Products: General Surgical Manual Instrument (FDA Code: MDM), Spinal Interlaminal Fixation Appliance (FDA Code: KWP), 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), ...
Tomz Corp. specializes in providing surgical instrumentation and implants. Our medical tooling, implants and components are made of titanium, cobalt, stainless steel and aluminum. more...
Vertebron, Inc. | Address: 80 Hathaway Drive, Stratford, Connecticut 06615, USA
www.vertebron.com | Send Inquiry | Phone: +1-(203)-380-9340
Products: Allografts, Pedicle Screw System, Cervical Plate System, Spinal Interlaminal Fixation Appliance (FDA Code: KWP), Spinal Intervertebral Body Fixation Appliance (FDA Code: KWQ), Spinal Pedicle Fixation Orthosis (FDA Code: MNI), ...
Vertebron, Inc. deals with spinal surgery products. We focus on motion preservation and dynamic stabilization. We offer a comprehensive line of products for thoracolumbar and cervical fusion procedure more...
www.vertebron.com | Send Inquiry | Phone: +1-(203)-380-9340
Products: Allografts, Pedicle Screw System, Cervical Plate System, Spinal Interlaminal Fixation Appliance (FDA Code: KWP), Spinal Intervertebral Body Fixation Appliance (FDA Code: KWQ), Spinal Pedicle Fixation Orthosis (FDA Code: MNI), ...
Vertebron, Inc. deals with spinal surgery products. We focus on motion preservation and dynamic stabilization. We offer a comprehensive line of products for thoracolumbar and cervical fusion procedure 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...
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FDA Code / Regulation: NKB / 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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