Spondylolisthesis Spinal Fixation Orthosis 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, Arthroscopes (FDA Code: HRX), Monopolar Electrode Cables, Electrode Cables (FDA Code: IKD), Surgical Mesh (FDA Code: FTM), Bipolar Electrode Cables, ...
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, Arthroscopes (FDA Code: HRX), Monopolar Electrode Cables, Electrode Cables (FDA Code: IKD), Surgical Mesh (FDA Code: FTM), Bipolar Electrode Cables, ...
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...
Exactech, Inc. | Address: 2320 North West 66th Court, Gainesville, Florida 32653, USA
www.exac.com | Send Inquiry | Phone: +1-(352)-377-1140, 800-392-2832
FDA Registration: 1038671 Year Established: 1985 Annual Revenues: USD 50-100 Million Employee Count: ~220 Quality: ISO 9001, CE Certified
Products: Patellar Implants, Primary Femoral Implants, Bone Cement (FDA Code: LOD), Bone grafting Osteotomes, Synthetic Bone Graft Substitute Granules, Bone Graft Substitute Plugs, ...
Exactech, Inc. is an orthopedic company that develops, manufactures, markets, distributes and sells orthopedic implant devices, related surgical instrumentation & biologic services to hospitals & phys more...
www.exac.com | Send Inquiry | Phone: +1-(352)-377-1140, 800-392-2832
FDA Registration: 1038671 Year Established: 1985 Annual Revenues: USD 50-100 Million Employee Count: ~220 Quality: ISO 9001, CE Certified
Products: Patellar Implants, Primary Femoral Implants, Bone Cement (FDA Code: LOD), Bone grafting Osteotomes, Synthetic Bone Graft Substitute Granules, Bone Graft Substitute Plugs, ...
Exactech, Inc. is an orthopedic company that develops, manufactures, markets, distributes and sells orthopedic implant devices, related surgical instrumentation & biologic services to hospitals & phys 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: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Saws (FDA Code: HSO), Sinus Trochars and Cannulae, Gastroenterologic Needle Holder (FDA Code: FHQ), Surgical Navigation Interface/Display, ...
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: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Saws (FDA Code: HSO), Sinus Trochars and Cannulae, Gastroenterologic Needle Holder (FDA Code: FHQ), Surgical Navigation Interface/Display, ...
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...
Scient'x USA Inc. | Address: 1015 Maitland Center Commons,Suite 106A, Maitland, Florida 32751, USA
www.scientxusa.com | Send Inquiry | Phone: +1-(,407)-571-2550
Year Established: 2002 Annual Revenues: USD 1-5 Million Employee Count: ~20 Quality: CE Certified
Products: Probes (FDA Code: HXB), Synthetic Spacers, Bioabsorbable synthetic spacers, Removable synthetic spacers, Drill Bit (FDA Code: HTW), Bone Taps (FDA Code: HWX), ...
Scient'x USA Inc. offers a wide range of anterior and posterior spinal fixation systems, which include proprietary semi-rigid lumbar system technology, its peek devices, its cervical plate, as well as more...
www.scientxusa.com | Send Inquiry | Phone: +1-(,407)-571-2550
Year Established: 2002 Annual Revenues: USD 1-5 Million Employee Count: ~20 Quality: CE Certified
Products: Probes (FDA Code: HXB), Synthetic Spacers, Bioabsorbable synthetic spacers, Removable synthetic spacers, Drill Bit (FDA Code: HTW), Bone Taps (FDA Code: HWX), ...
Scient'x USA Inc. offers a wide range of anterior and posterior spinal fixation systems, which include proprietary semi-rigid lumbar system technology, its peek devices, its cervical plate, as well as 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: Heat or Cold Packs, Blades, Drills, Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Saws (FDA Code: HSO), ...
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: Heat or Cold Packs, Blades, Drills, Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Saws (FDA Code: HSO), ...
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...
Zimmer, Inc. | Address: P.O. Box 708 ,1800 West Center Street, Warsaw, Indiana 46581-0708, USA
www.zimmer.com | Phone: +1-(574)-372-4790, 800-613-6131
FDA Registration: 1822565 Year Established: 1927 Annual Revenues: > USD 1 Billion Employee Count: ~7600 Quality: ISO 9001, CE Certified
Products: Splints, Forceps (FDA Code: HTD), Saws (FDA Code: HSO), Spreaders, Silicone Tubing, Dressing Forceps, ...
Zimmer, Inc. manufactures orthopedic products and instruments. We specialize in joint replacement solutions for knee pain & hip pain. We deliver comprehensive spine care solutions for acute and chroni more...
www.zimmer.com | Phone: +1-(574)-372-4790, 800-613-6131
FDA Registration: 1822565 Year Established: 1927 Annual Revenues: > USD 1 Billion Employee Count: ~7600 Quality: ISO 9001, CE Certified
Products: Splints, Forceps (FDA Code: HTD), Saws (FDA Code: HSO), Spreaders, Silicone Tubing, Dressing Forceps, ...
Zimmer, Inc. manufactures orthopedic products and instruments. We specialize in joint replacement solutions for knee pain & hip pain. We deliver comprehensive spine care solutions for acute and chroni 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: Vaginal Retractors (FDA Code: HDL), Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Light Sources, Visual Acuity Charts (FDA Code: HOX), Surgical Headlights, ...
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: Vaginal Retractors (FDA Code: HDL), Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Light Sources, Visual Acuity Charts (FDA Code: HOX), Surgical Headlights, ...
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: Cables, Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Skull Clamps and Pins, Synthetic Spacers, Occipital Fixation Systems, ...
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: Cables, Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Skull Clamps and Pins, Synthetic Spacers, Occipital Fixation Systems, ...
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: Probes (FDA Code: HXB), Posterior, Plating Systems, Arthroscopes (FDA Code: HRX), Bone Rasps (FDA Code: HTR), Bio Absorbable Plating Systems, ...
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: Probes (FDA Code: HXB), Posterior, Plating Systems, Arthroscopes (FDA Code: HRX), Bone Rasps (FDA Code: HTR), Bio Absorbable Plating Systems, ...
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...
Endotec, Inc. | Address: 20 Valley Street, South Orange, New Jersey 07079, USA
www.endotec.com | Send Inquiry | Phone: +1-(973)-672-9300
FDA Registration: 3006001176
Products: Total Ankle Systems, Bone Fixation Screw (FDA Code: HWC), Humeral (hemi-shoulder) Metallic Uncemented Prosthesis (FDA Code: HSD), Humeral Shoulder Prosthesis (FDA Code: MJT), Hip Joint (Hemi- Hip) Acetabular Metal Cemented Prosthesis (FDA Code: KWB), Femoral Metal Ball Hemi Hip Prosthesis (FDA Code: LZY), ...
Endotec, Inc. is a manufacturer, distributor & designer of orthopedic and maxillofacial implants. We offer products such as hip system, shoulder system, knee system & TMJ system. We offer the B-P inte more...
www.endotec.com | Send Inquiry | Phone: +1-(973)-672-9300
FDA Registration: 3006001176
Products: Total Ankle Systems, Bone Fixation Screw (FDA Code: HWC), Humeral (hemi-shoulder) Metallic Uncemented Prosthesis (FDA Code: HSD), Humeral Shoulder Prosthesis (FDA Code: MJT), Hip Joint (Hemi- Hip) Acetabular Metal Cemented Prosthesis (FDA Code: KWB), Femoral Metal Ball Hemi Hip Prosthesis (FDA Code: LZY), ...
Endotec, Inc. is a manufacturer, distributor & designer of orthopedic and maxillofacial implants. We offer products such as hip system, shoulder system, knee system & TMJ system. We offer the B-P inte 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, Spinal Motion Preservation 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, Spinal Motion Preservation 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...
Aesculap Inc. | Address: 3773 Corporate Parkway, Center Valley, Pennsylvania 18034, USA
www.aesculapusa.com | Send Inquiry | Phone: +1-(800)-258-1946
FDA Registration: 2916714 Year Established: 1977 Annual Revenues: USD 1-5 Million Employee Count: ~120
Products: Vaginal Retractors (FDA Code: HDL), Curettes, Drills, Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Uterine Sound Instruments, ...
Aesculap Inc. manufactures surgical instrumentation. Our products include surgical instruments, laparoscopy, endoscopy, neurosurgery, sutrures, surgical quality management, and consulting services. Ou more...
www.aesculapusa.com | Send Inquiry | Phone: +1-(800)-258-1946
FDA Registration: 2916714 Year Established: 1977 Annual Revenues: USD 1-5 Million Employee Count: ~120
Products: Vaginal Retractors (FDA Code: HDL), Curettes, Drills, Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Uterine Sound Instruments, ...
Aesculap Inc. manufactures surgical instrumentation. Our products include surgical instruments, laparoscopy, endoscopy, neurosurgery, sutrures, surgical quality management, and consulting services. Ou more...
Wright Medical Technology, Inc. | Address: 5677 Airline Road, Arlington, Tennessee 38002, USA
www.wmt.com | Send Inquiry | Phone: +1-(901)-867-9971, 800-238-7117
FDA Registration: 3012429289 Year Established: 1950 Annual Revenues: USD 100-500 Million Employee Count: ~1000 Quality: ISO 9002, ISO 9003, CE Certified
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Saws (FDA Code: HSO), Tibial Inserts, Patellar Implants, Metal and Ceramic Liners, ...
Wright Medical Technology, Inc. is a global orthopaedic medical device company. Our Advance® Uni-Knee renders normal motion and leads to a longer implant life that delays or prevents the need for more...
www.wmt.com | Send Inquiry | Phone: +1-(901)-867-9971, 800-238-7117
FDA Registration: 3012429289 Year Established: 1950 Annual Revenues: USD 100-500 Million Employee Count: ~1000 Quality: ISO 9002, ISO 9003, CE Certified
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Saws (FDA Code: HSO), Tibial Inserts, Patellar Implants, Metal and Ceramic Liners, ...
Wright Medical Technology, Inc. is a global orthopaedic medical device company. Our Advance® Uni-Knee renders normal motion and leads to a longer implant life that delays or prevents the need for 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: Probes (FDA Code: HXB), Femoral IM Nails, Ankle External Fixators, Elbow External Fixators, Hand External Fixators, Static External Fixators, ...
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: Probes (FDA Code: HXB), Femoral IM Nails, Ankle External Fixators, Elbow External Fixators, Hand External Fixators, Static External Fixators, ...
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: Probes (FDA Code: HXB), Arthroscopes (FDA Code: HRX), Bone Rasps (FDA Code: HTR), Surgical Retractor Systems (FDA Code: GAD), Bone Mallets (FDA Code: HXL), Human Bone Rasps (FDA Code: HTR), ...
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: Probes (FDA Code: HXB), Arthroscopes (FDA Code: HRX), Bone Rasps (FDA Code: HTR), Surgical Retractor Systems (FDA Code: GAD), Bone Mallets (FDA Code: HXL), Human Bone Rasps (FDA Code: HTR), ...
EBI Patient Care, Inc. provides braces thermal therapy devices, spinal endoscopic system and cast bandage. more...
Ultimate Spine, LLC. | Address: 1220 North Barsten Way, Anaheim, California 92806, USA
Phone: +1-(562)-598-1753
Products: Spinal Pedicle Fixation Orthosis (FDA Code: MNI), Spondylolisthesis Spinal Fixation Orthosis (FDA Code: MNH), ...
Ultimate Spine, LLC. produces selective axis posterior noncervical plating systems. more...
Phone: +1-(562)-598-1753
Products: Spinal Pedicle Fixation Orthosis (FDA Code: MNI), Spondylolisthesis Spinal Fixation Orthosis (FDA Code: MNH), ...
Ultimate Spine, LLC. produces selective axis posterior noncervical plating systems. more...
Orthotec, LLC | Address: 9595 Wilshire Blvd., Suite 502, Beverly Hills, California 90212-4110, USA
www.orthotec.net | Send Inquiry | Phone: +1-(310)-273-1500, 800-557-2988
Year Established: 1998 Annual Revenues: < USD 1 Million Quality: ISO Certified
Products: 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), ...
Orthotec, LLC develops spinal systems. Our products address the pathologies of the entire spine. Our spinal systems are recognized by neurosurgeons, orthopedic and spine surgeons. Our compression load more...
www.orthotec.net | Send Inquiry | Phone: +1-(310)-273-1500, 800-557-2988
Year Established: 1998 Annual Revenues: < USD 1 Million Quality: ISO Certified
Products: 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), ...
Orthotec, LLC develops spinal systems. Our products address the pathologies of the entire spine. Our spinal systems are recognized by neurosurgeons, orthopedic and spine surgeons. Our compression load more...
Kodent Inc. | Address: 325 N Puente St., Unit B, Brea, California 92821, USA
Send Inquiry | Phone: +1-(714)-525-0114
Products: Moist Heat Pack (FDA Code: IMA), Collagen Wound Dressing (FDA Code: KGN), Spinal Interlaminal Fixation Appliance (FDA Code: KWP), Spinal Pedicle Fixation Orthosis (FDA Code: MNI), Spondylolisthesis Spinal Fixation Orthosis (FDA Code: MNH), Drug Wound Dressing (FDA Code: FRO), ...
Kodent Inc. specializes in providing implant systems. more...
Send Inquiry | Phone: +1-(714)-525-0114
Products: Moist Heat Pack (FDA Code: IMA), Collagen Wound Dressing (FDA Code: KGN), Spinal Interlaminal Fixation Appliance (FDA Code: KWP), Spinal Pedicle Fixation Orthosis (FDA Code: MNI), Spondylolisthesis Spinal Fixation Orthosis (FDA Code: MNH), Drug Wound Dressing (FDA Code: FRO), ...
Kodent Inc. specializes in providing implant systems. 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: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Bone Rasps (FDA Code: HTR), Wire Twisters (FDA Code: HXS), Surgical Trays (FDA Code: LRP), Surgical Retractor Systems (FDA Code: GAD), ...
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: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Bone Rasps (FDA Code: HTR), Wire Twisters (FDA Code: HXS), Surgical Trays (FDA Code: LRP), Surgical Retractor Systems (FDA Code: GAD), ...
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: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Saws (FDA Code: HSO), Arthroscopes (FDA Code: HRX), Bone Hooks (FDA Code: KIK), Bone Rasps (FDA Code: HTR), ...
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: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Saws (FDA Code: HSO), Arthroscopes (FDA Code: HRX), Bone Hooks (FDA Code: KIK), Bone Rasps (FDA Code: HTR), ...
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...
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FDA Code / Regulation: MNH / 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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