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US Food and Drug Administration (FDA) - Orthopedic Devices Registration |
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US Food and Drug Administration (FDA) - Orthopedic Devices Registration |
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Classification: WASHER, BOLT NUT Generic Device Name: VARIOUS BOLTS AND NUTS Proprietary Device Name: MULTIPLE Registered Establishment Name: MEDTRONIC SOFAMOR DANEK USA, INC.. |
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Classification: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT Generic Device Name: SCREWDRIVERS, WRENCHES, TAPS, GUIDE PINS, ETC. Proprietary Device Name: MULTIPLE Registered Establishment Name: MEDTRONIC SOFAMOR DANEK USA, INC.. |
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Classification: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, SINGLE COMPONENT Generic Device Name: PLATE Proprietary Device Name: MULTIPLE Registered Establishment Name: MEDTRONIC SOFAMOR DANEK USA, INC.. |
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Classification: RONGEUR Generic Device Name: VARIOUS (RONGEURS) Proprietary Device Name: MULTIPLE (RONGEURS) Registered Establishment Name: MEDTRONIC SOFAMOR DANEK USA, INC.. |
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Classification: EXTRACTOR Generic Device Name: MULTIPLE (DRIVER-EXTRACTORS) Proprietary Device Name: MULTIPLE (DRIVER-EXTRACTORS) Registered Establishment Name: MEDTRONIC SOFAMOR DANEK USA, INC.. |
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Classification: CEMENT OBTURATOR Generic Device Name: CEMENT RESTRICTOR Proprietary Device Name: TCR, PCR, SHADOW CR, THREADED CR Registered Establishment Name: MEDTRONIC SOFAMOR DANEK USA, INC.. |
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Classification: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE Generic Device Name: INTERBODY FIXATOR Proprietary Device Name: VERTE-SPAN SPINAL SYSTEM Registered Establishment Name: MEDTRONIC SOFAMOR DANEK USA, INC.. |
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Classification: STAPLE, FIXATION, BONE Generic Device Name: STAPLE Proprietary Device Name: DYNAMIC COMPRESSION STAPLE SYSTEM Registered Establishment Name: MEDTRONIC SOFAMOR DANEK USA, INC.. |
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Classification: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE Generic Device Name: METALLIC BONE FIXATION DEVICE Proprietary Device Name: TSRH SPINAL SYSTEM, CD HORIZON SPINAL SYSTEM Registered Establishment Name: MEDTRONIC SOFAMOR DANEK USA, INC.. |
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Classification: FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH METAL PROSTHESIS, OSTEOINDUCTION Generic Device Name: COLLAGEN SPONGE Proprietary Device Name: INFUSE BONE GRAFT Registered Establishment Name: MEDTRONIC SOFAMOR DANEK USA, INC.. |
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Classification: FILLER, BONE VOID, CALCIUM COMPOUND Generic Device Name: BONE, VOID FILLER Proprietary Device Name: MASTERGRAFT BONE VOID FILLER Registered Establishment Name: MEDTRONIC SOFAMOR DANEK USA, INC.. |
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Classification: ORTHOSIS, SPINAL INTERVERTEBRAL FUSION Generic Device Name: SPINAL FUSION DEVICE Proprietary Device Name: INTERFIX TM THREADED FUSION DEVICE Registered Establishment Name: MEDTRONIC SOFAMOR DANEK USA, INC.. |
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Classification: SCREW, FIXATION, BONE Generic Device Name: BONE SCREW Proprietary Device Name: SCREW, FIXATION, BONE Registered Establishment Name: MEDTRONIC SOFAMOR DANEK USA, INC.. |
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Classification: APPLIANCE, FIXATION, SPINAL INTERLAMINAL Generic Device Name: INTERLAMINAL CLAMP Proprietary Device Name: APOFIX Registered Establishment Name: MEDTRONIC SOFAMOR DANEK USA, INC.. |
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Classification: ORTHOSIS, SPONDYLOISTHESIS SPINAL FIXATION Generic Device Name: MULTI-AXIAL SCREW Proprietary Device Name: ALPHA POSTERIOR SPINAL SYSTEM Registered Establishment Name: MEDTRONIC SOFAMOR DANEK USA, INC.. |
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Classification: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL Generic Device Name: THOMPSON Proprietary Device Name: THOMPSON TYPE Registered Establishment Name: MEDTRONIC SOFAMOR DANEK USA, INC.. |
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Classification: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS CEMENTED, OSTEOPHILIC FINISH Generic Device Name: MUELLER Proprietary Device Name: MUELLER TYPE Registered Establishment Name: MEDTRONIC SOFAMOR DANEK USA, INC.. |
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Classification: IMPACTOR Generic Device Name: IMPACTOR Proprietary Device Name: MULTIPLE Registered Establishment Name: MEDTRONIC SOFAMOR DANEK USA, INC.. |
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Classification: AWL Generic Device Name: AWL Proprietary Device Name: MULTIPLE Registered Establishment Name: MEDTRONIC SOFAMOR DANEK USA, INC.. |
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Classification: BENDER Generic Device Name: VARIOUS BENDERS Proprietary Device Name: MULTIPLE Registered Establishment Name: MEDTRONIC SOFAMOR DANEK USA, INC.. |
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Classification: FORK Generic Device Name: FORK, FORK HAMMER Proprietary Device Name: MULTIPLE Registered Establishment Name: MEDTRONIC SOFAMOR DANEK USA, INC.. |
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Classification: PUSHER, SOCKET Generic Device Name: SOCKET Proprietary Device Name: MULTIPLE Registered Establishment Name: MEDTRONIC SOFAMOR DANEK USA, INC.. |
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Classification: PROSTHESIS, INTERVERTEBRAL DISC Generic Device Name: INTERVERTEBRAL DISC PROSTHESIS Proprietary Device Name: BRYAN TOTAL CERVICAL DISC,PRESTIGE CERVICAL DISC,MAVERICK TOTAL DISC REPLACEMENT Registered Establishment Name: MEDTRONIC SOFAMOR DANEK USA, INC.. |
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Classification: SCISSORS, ORTHOPEDIC, SURGICAL Generic Device Name: MULTIPLE (SCISSORS) Proprietary Device Name: MULTIPLE (SCISSORS) Registered Establishment Name: MEDTRONIC SOFAMOR DANEK USA, INC.. |
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Classification: CUTTER, WIRE Generic Device Name: VARIOUS TYPES OF ORTHOPEDIC WIRE CUTTERS Proprietary Device Name: MULTIPLE Registered Establishment Name: MEDTRONIC SOFAMOR DANEK USA, INC.. |
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Classification: COUNTERSINK Generic Device Name: COUNTERSINK Proprietary Device Name: COUNTERSINK Registered Establishment Name: MEDTRONIC SOFAMOR DANEK USA, INC.. |
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Classification: INSTRUMENT, COMPRESSION Generic Device Name: PLATE AND SCREW COMPRESSION DEVICES Proprietary Device Name: MULTIPLE Registered Establishment Name: MEDTRONIC SOFAMOR DANEK USA, INC.. |
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Classification: WRENCH Generic Device Name: VARIOUS TYPES OF ORTHOPEDIC WRENCHES Proprietary Device Name: MULTIPLE Registered Establishment Name: MEDTRONIC SOFAMOR DANEK USA, INC.. |
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Classification: SCREWDRIVER Generic Device Name: SCREWDRIVER, ORTHOPEDIC Proprietary Device Name: MULTIPLE Registered Establishment Name: MEDTRONIC SOFAMOR DANEK USA, INC.. |
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Classification: TAMP Generic Device Name: MULTPLE TAMPS Proprietary Device Name: MULTIPLE Registered Establishment Name: MEDTRONIC SOFAMOR DANEK USA, INC.. |
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Classification: ACCESSORIES,ARTHROSCOPIC Generic Device Name: ARTHROSCOPE Proprietary Device Name: ARTHROSCOPE Registered Establishment Name: MEDTRONIC SOFAMOR DANEK USA, INC.. |
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Classification: INSTRUMENT, BENDING OR CONTOURING Generic Device Name: VARIOUS ROD BENDERS Proprietary Device Name: ROD BENDER Registered Establishment Name: MEDTRONIC SOFAMOR DANEK USA, INC.. |
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Classification: DEVICE, FIXATION, PROXIMAL FEMORAL, IMPLANT Generic Device Name: MULTIPLE (PROXIMAL FEMORAL FIXATION DEVICES, NAILS, PLATES, SCREWS, PINS) Proprietary Device Name: MULTIPLE (PROXIMAL FEMORAL FIXATION DEVICES, NAILS, PLATES, SCREWS, PINS) Registered Establishment Name: MEDTRONIC SOFAMOR DANEK USA, INC.. |
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Classification: GAUGE, DEPTH Generic Device Name: MULTIPLE (DEPTH GAUGES) Proprietary Device Name: MULTIPLE (DEPTH GAUGES) Registered Establishment Name: MEDTRONIC SOFAMOR DANEK USA, INC.. |
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Classification: PIN, FIXATION, THREADED Generic Device Name: THREADED K-WIRE/STEINMAN PINS Proprietary Device Name: THREADED K-WIRE/STEINMAN PINS Registered Establishment Name: BRASSELER USA I, L.P.. |
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Classification: PIN, FIXATION, SMOOTH Generic Device Name: SMOOTH K-WIRE/STEINMAN PINS Proprietary Device Name: SMOOTH K-WIRE/STEINMAN PINS Registered Establishment Name: BRASSELER USA I, L.P.. |
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Classification: BURR, ORTHOPEDIC Generic Device Name: VARIOUS TYPES OF BURRS Registered Establishment Name: WALTER LORENZ SURGICAL, INC.. |
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Classification: AWL Registered Establishment Name: WALTER LORENZ SURGICAL, INC.. |
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Classification: PLATE, FIXATION, BONE Generic Device Name: RETROSTERNAL STRUT Proprietary Device Name: LORENZ PECTUS SUPPORT BAR Registered Establishment Name: WALTER LORENZ SURGICAL, INC.. |
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Classification: GONIOMETER, NONPOWERED Generic Device Name: VARIOUS TYPES OF GONIOMETERS Proprietary Device Name: MULTIPLE Registered Establishment Name: WALTER LORENZ SURGICAL, INC.. |
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