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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: SCREW, FIXATION, BONE Generic Device Name: SNAP-OFF BONE SCREW, NON-STERILE Proprietary Device Name: MERETE TWISTCUT SNAP-OFF/DUOTHREADTM BONE SCREW Registered Establishment Name: MERETE MEDICAL GMBH. |
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Classification: COUNTERSINK Generic Device Name: BONE SCREW COUNTERSINK Proprietary Device Name: BONE SCREW COUNTERSINK Registered Establishment Name: MERETE MEDICAL GMBH. |
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Classification: SCREWDRIVER Generic Device Name: SCREW DRIVER ORTHOPEDIC Proprietary Device Name: SCREW DRIVER ORTHOPEDIC Registered Establishment Name: MERETE MEDICAL GMBH. |
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Classification: GAUGE, DEPTH Generic Device Name: BONE SCREW DEPTH GAUGE Proprietary Device Name: BONE SCREW DEPTH GAUGE Registered Establishment Name: MERETE MEDICAL GMBH. |
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Classification: BIT, DRILL Generic Device Name: VARIOUS TWIST DRILLS Proprietary Device Name: VARIOUS TWIST DRILLS Registered Establishment Name: MERETE MEDICAL GMBH. |
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Classification: INSTRUMENT, BENDING OR CONTOURING Generic Device Name: VARIOUS TYPES OF BENDING INSTRUMENTS Proprietary Device Name: MULTIPLE TYPES OF BENDING INSTRUMENTS Registered Establishment Name: MERETE MEDICAL GMBH. |
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Classification: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT Generic Device Name: SMALL FRAGMENT LOCKING BONE PLATE NON-STERILE Proprietary Device Name: MERETE METAFIX SMALL FRAGMENT BONE PLATE SYSTEM Registered Establishment Name: MERETE MEDICAL GMBH. |
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Classification: APPARATUS, TRACTION, NON-POWERED Generic Device Name: THERABOOT Proprietary Device Name: THERABOOT Registered Establishment Name: AZAR GROUP INTL. INC.. |
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Classification: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE Generic Device Name: BROW LIFT DEVICE & INSTALLATION KIT Proprietary Device Name: ENDSTINE (TM) Registered Establishment Name: COAPT SYSTEMS, INC.. |
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Classification: SCREW, FIXATION, BONE Generic Device Name: BROW,MIDFACE LIFT DEVICE AND INSTALLATION TOOLS Proprietary Device Name: ENDOTINE TRANSBLEPH,TRIPLE,MIDFACE BONE Registered Establishment Name: COAPT SYSTEMS, INC.. |
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Classification: FILLER, BONE VOID, CALCIUM COMPOUND Generic Device Name: DEMINERALIZED BONE MATRIX PRODUCTS Proprietary Device Name: ORTHOBLAST II PUTTY & GEL Registered Establishment Name: ISOTIS ORTHOBIOLOGICS, INC. |
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Classification: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Generic Device Name: INTRAMEDULLARY NAIL Proprietary Device Name: FASSIER-DUVAL TELESCOPIC IM SYSTEM Registered Establishment Name: PEGA MEDICAL INC.. |
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Classification: PIN, FIXATION, THREADED Generic Device Name: DISTRACTION PIN Proprietary Device Name: NBD DISTRACTION PIN Registered Establishment Name: NEW BUSINESS DEVELOPMENT, LLC. |
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Classification: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY Generic Device Name: ANTERIOR FIXATION DEVICES Proprietary Device Name: MULTIPLE, TSRH, CD HORIZON, DYNALOK, ATLANTIS, ZPLATE-ATL, PYRAMID, VERTE-STACK Registered Establishment Name: MEDTRONIC SOFAMOR DANEK USA, INC.. |
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Classification: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT Generic Device Name: VARIOUS SURGICAL BURS Proprietary Device Name: MULTIPLE Registered Establishment Name: MEDTRONIC SOFAMOR DANEK USA, INC.. |
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Classification: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Generic Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Proprietary Device Name: MULTIPLE Registered Establishment Name: MEDTRONIC SOFAMOR DANEK USA, INC.. |
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Classification: CRIMPER, PIN Generic Device Name: VARIOUS TENSION CRIMPER Proprietary Device Name: MULTIPLE Registered Establishment Name: MEDTRONIC SOFAMOR DANEK USA, INC.. |
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Classification: REAMER Generic Device Name: MULTIPLE (ORTHOPEDIC REAMERS) Proprietary Device Name: MULTIPLE (ORTHOPEDIC REAMERS) Registered Establishment Name: MEDTRONIC SOFAMOR DANEK USA, INC.. |
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Classification: BIT, DRILL Generic Device Name: VARIOUS TWIST, BIT DRILLS Proprietary Device Name: MULTIPLE TWIST, BIT DRILLS 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: 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 (TM) BONE VOID FILLER 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: 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: 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: COUNTERSINK Generic Device Name: COUNTERSINK Proprietary Device Name: COUNTERSINK 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: 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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