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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: PLATE, FIXATION, BONE Generic Device Name: METALLIC BONE FIXATION APPLIANCES AND ACCESSORIES Proprietary Device Name: PLATE, FIXATION, BONE Registered Establishment Name: KAPP SURGICAL INSTRUMENT, INC.. |
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Classification: PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER Generic Device Name: RADIAL HEAD IMPLANT Proprietary Device Name: KAPP CUSTOM RADIAL HEAD ELBOW IMPLANT Registered Establishment Name: KAPP SURGICAL INSTRUMENT, INC.. |
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Classification: PROSTHESIS, WRIST, HEMI-, ULNAR Generic Device Name: ULNAR HEAD IMPLANT Proprietary Device Name: KAPP CUSTOM ULNAR HEAD WRIST IMPLANT Registered Establishment Name: KAPP SURGICAL INSTRUMENT, INC.. |
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Classification: APPARATUS, TRACTION, NON-POWERED Generic Device Name: VARIOUS STYLES OF WEIGHT CARTS Proprietary Device Name: WEIGHT CART Registered Establishment Name: BAILEY MFG. CO.. |
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Classification: SPLINT, TRACTION Generic Device Name: ADJUSTABLE, LEG, TRACTION SPLINT Proprietary Device Name: FERNO MODEL 668 TRACTION SPLINT Registered Establishment Name: FERNO-WASHINGTON, INC.. |
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Classification: SPLINT, TRACTION Generic Device Name: BOARD SPLINTS Proprietary Device Name: BOARD SPLINTS Registered Establishment Name: MORRISON MEDICAL PRODUCTS. |
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Classification: APPARATUS, TRACTION, NON-POWERED Generic Device Name: ANKLE HITCH Proprietary Device Name: ANKLE HITCH Registered Establishment Name: MORRISON MEDICAL PRODUCTS. |
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Classification: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Generic Device Name: VARIOUS TYPES OF ORTHOPEDIC INSTRUMENTS (DEPTH GAUGE, RETRACTOR) Proprietary Device Name: ACROMED DEPTH GAUGE;ACROMED SPINAL RETRACTOR Registered Establishment Name: DEPUY SPINE, INC.. |
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Classification: PLATE, FIXATION, BONE Generic Device Name: BONE PLATES Proprietary Device Name: VSP BONE PLATE Registered Establishment Name: DEPUY SPINE, INC.. |
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Classification: SCREW, FIXATION, BONE Generic Device Name: BONE SCREW Proprietary Device Name: VSP BONE SCREW, ISOLA SACRAL SCREW Registered Establishment Name: DEPUY SPINE, INC.. |
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Classification: CUTTER, WIRE Generic Device Name: SCREW/BOLT CUTTER Proprietary Device Name: VSP SCREW (END) CUTTER Registered Establishment Name: DEPUY SPINE, INC.. |
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Classification: RONGEUR Generic Device Name: VARIOUS SIZES AND CONFIGURATIONS OF RONGEURS Proprietary Device Name: ACROMED DISC RONGEURS Registered Establishment Name: DEPUY SPINE, INC.. |
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Classification: TEMPLATE Generic Device Name: TEMPLATE Proprietary Device Name: VSP ALUMINUM CONTOURING TEMPLATE SET Registered Establishment Name: DEPUY SPINE, INC.. |
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Classification: REAMER Generic Device Name: VARIOUS SIZES OF SURGICAL ORTHOPAEDIC REAMERS Proprietary Device Name: ADS PLIF PILOT REAMER Registered Establishment Name: DEPUY SPINE, INC.. |
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Classification: BIT, DRILL Generic Device Name: VARIOUS SIZES OF SURGICAL DRILL BITS Proprietary Device Name: ADS PLIF TWIST DRILL Registered Establishment Name: DEPUY SPINE, INC.. |
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Classification: GONIOMETER, NONPOWERED Generic Device Name: GONIOMETER Proprietary Device Name: ISOLA GONIOMETER Registered Establishment Name: DEPUY SPINE, INC.. |
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Classification: WASHER, BOLT NUT Generic Device Name: WASHER, NUT, BOLT Proprietary Device Name: VSP PLATE SPACER WASHER, VSP TAPERED PLATE WASHER, VSP TAPER Registered Establishment Name: DEPUY SPINE, INC.. |
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Classification: SCREWDRIVER Generic Device Name: SCREWDRIVER, HEXHEAD Proprietary Device Name: ISOLA 1/8" HEX SCREWDRIVER Registered Establishment Name: DEPUY SPINE, INC.. |
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Classification: IMPLANT, FIXATION DEVICE, SPINAL Generic Device Name: VARIOUS SPINAL HOOKS, RODS, COUPLERS, WIRES AND RELATED INSTRUMENT Proprietary Device Name: ISOLA SPINAL IMPLANT SYSTEM AND KANEDA ANTERIOR SPINAL IMPLA Registered Establishment Name: DEPUY SPINE, INC.. |
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Classification: BROACH Generic Device Name: VARIOUS SIZES OF BROACHES Proprietary Device Name: ADS PLIF BROACH Registered Establishment Name: DEPUY SPINE, INC.. |
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Classification: NAIL, FIXATION, BONE Generic Device Name: BONE NAIL Proprietary Device Name: ACROMED BONE NAIL Registered Establishment Name: DEPUY SPINE, INC.. |
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Classification: KNIFE, ORTHOPEDIC Generic Device Name: DISSECTOR, SURGICAL KNIFE Proprietary Device Name: NEURAL DISSECTOR Registered Establishment Name: DEPUY SPINE, INC.. |
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Classification: PROBE Generic Device Name: ORTHOPAEDIC PROBE Proprietary Device Name: VSP BONE PROBE Registered Establishment Name: DEPUY SPINE, INC.. |
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Classification: PUNCH, FEMORAL NECK Generic Device Name: BONE SCREW EXTRACTOR Proprietary Device Name: VSP SCREW EXTRACTOR Registered Establishment Name: DEPUY SPINE, INC.. |
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Classification: TAP, BONE Generic Device Name: BONE TAP Proprietary Device Name: VSP BONE TAP Registered Establishment Name: DEPUY SPINE, INC.. |
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Classification: WRENCH Generic Device Name: ORTHOPAEDIC WRENCH Proprietary Device Name: MULTIPLE Registered Establishment Name: DEPUY SPINE, INC.. |
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Classification: TAMP Generic Device Name: IMPACTOR Proprietary Device Name: DOUBLE ENDED IMPACTOR Registered Establishment Name: DEPUY SPINE, INC.. |
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Classification: INSTRUMENT, BENDING OR CONTOURING Generic Device Name: CONTOURING INSTRUMENT Proprietary Device Name: MULTIPLE: VSP PLATE BENDER Registered Establishment Name: DEPUY SPINE, INC.. |
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Classification: AWL Generic Device Name: ORTHOPAEDIC AWL Proprietary Device Name: WALLIE-HEINIG TROCAR Registered Establishment Name: DEPUY SPINE, INC.. |
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Classification: TREPHINE Generic Device Name: TREPHINEA Proprietary Device Name: SCREW REMOVER Registered Establishment Name: DEPUY SPINE, INC.. |
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Classification: ARTHROSCOPE Generic Device Name: MANUAL ENDOSCOPIC INSTRUMENTS Proprietary Device Name: AETI INSTRUMENTS Registered Establishment Name: DEPUY SPINE, INC.. |
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Classification: ORTHOSIS, FIXATION, SPINAL CERVICAL INTERVERTEBRAL BODY Generic Device Name: CERVICAL ANTERIOR PLATE Proprietary Device Name: ACROPLATE ANTERIOR CERVICAL PLATING SYSTEM Registered Establishment Name: DEPUY SPINE, INC.. |
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Classification: FILLER, BONE VOID, CALCIUM COMPOUND Generic Device Name: B-TRICALCIUM PHOSPHATE Proprietary Device Name: CONDUIT TCP GRANUELS Registered Establishment Name: DEPUY SPINE, INC.. |
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Classification: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE Generic Device Name: STACKABLE CAGE Proprietary Device Name: STACKABLE CAGE Registered Establishment Name: DEPUY SPINE, INC.. |
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Classification: APPLIANCE, FIXATION, SPINAL INTERLAMINAL Generic Device Name: PEDICLE SCREW Proprietary Device Name: ACROD PEDICLE SCREW Registered Establishment Name: DEPUY SPINE, INC.. |
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Classification: ORTHOSIS, SPINAL PEDICLE FIXATION Generic Device Name: PEDICLE SCREW Proprietary Device Name: ACRO MED PEDICLE SCREW Registered Establishment Name: DEPUY SPINE, INC.. |
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Classification: ORTHOSIS, SPONDYLOISTHESIS SPINAL FIXATION Generic Device Name: MED PEDICLE SCREW Proprietary Device Name: ACRO MED PEDICLE SCREW Registered Establishment Name: DEPUY SPINE, INC.. |
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Classification: ORTHOSIS, SPINAL INTERVERTEBRAL FUSION Generic Device Name: INTERBODY FUSION CAGE AND POSTERIOR PEDICLE SCREW FIXATION SYSTEM-STERILE AND NO Proprietary Device Name: INTERBODY FUSION CAGE AND POSTERIOR PEDICLE SCREW FIXATION SYSTEM-STERILE AND NO Registered Establishment Name: DEPUY SPINE, INC.. |
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Classification: GAUGE, DEPTH Generic Device Name: DEPTH GAUGE Proprietary Device Name: ACROMED DEPTH GAUGE Registered Establishment Name: DEPUY SPINE, INC.. |
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Classification: CALIPER Generic Device Name: CALIPER Proprietary Device Name: ISOLA STRAIGHT CALIPERS Registered Establishment Name: DEPUY SPINE, INC.. |
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