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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: IMPACTOR Generic Device Name: IMPACTOR Proprietary Device Name: EXACTECH IMPACTOR Registered Establishment Name: EXACTECH, INC.. |
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Classification: INSTRUMENT, COMPRESSION Generic Device Name: INSTRUMENT, COMPRESSION Proprietary Device Name: EXACTECH IMPLANT ASSEMBLER PLIERS Registered Establishment Name: EXACTECH, INC.. |
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Classification: PUNCH, FEMORAL NECK Generic Device Name: PUNCH, FEMORAL NECK Proprietary Device Name: M-SERIES ROUND OSTEOTOME Registered Establishment Name: EXACTECH, INC.. |
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Classification: TAMP Generic Device Name: TAMP Proprietary Device Name: EXACTECH TIBIAL TAMPS Registered Establishment Name: EXACTECH, INC.. |
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Classification: SCREWDRIVER Generic Device Name: SCREWDRIVER Proprietary Device Name: EXACTECH SURGICAL SCREWDRIVER Registered Establishment Name: EXACTECH, INC.. |
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Classification: POSITIONER, SOCKET Generic Device Name: POSITIONER, SOCKET Proprietary Device Name: EXACTECH ACETABULAR LINER INSERTER Registered Establishment Name: EXACTECH, INC.. |
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Classification: DRIVER, PROSTHESIS Generic Device Name: PROSTHESIS DRIVER Proprietary Device Name: FEMORAL STEM DRIVER Registered Establishment Name: EXACTECH, INC.. |
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Classification: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED Generic Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED Proprietary Device Name: ACUMATCH L-SERIES & P-SERIES FEMORAL STEM Registered Establishment Name: EXACTECH, INC.. |
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Classification: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, METAL/POLYMER, MOBILE BEARING Generic Device Name: MOBILE BEARING KNEE Proprietary Device Name: OPTETRAK RBK Registered Establishment Name: EXACTECH, INC.. |
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Classification: PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED Generic Device Name: HEMI-SHOULDER JOINT PROSTHESIS Proprietary Device Name: MULTIPLE Registered Establishment Name: EXACTECH, INC.. |
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Classification: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED Generic Device Name: SHOULDER JOINT PROSTHESIS Proprietary Device Name: MULTIPLE Registered Establishment Name: EXACTECH, INC.. |
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Classification: PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER Generic Device Name: CONSTRAINED ACETABULAR HIP PROSTHESIS Proprietary Device Name: MULTIPLE Registered Establishment Name: EXACTECH, INC.. |
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Classification: BONE MILL Generic Device Name: BONE MILL Proprietary Device Name: BONE MILL Registered Establishment Name: IMPLANT INNOVATIONS, INC.. |
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Classification: COMPONENT, CAST Generic Device Name: CAST SHOE Proprietary Device Name: MULTIPLE Registered Establishment Name: BSN MEDICAL, INC.. |
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Classification: INSTRUMENT, CAST APPLICATION/REMOVAL, MANUAL Generic Device Name: VARIOUS TYPES OF SCISSORS, SHEARS AND SPREADERS Proprietary Device Name: MULTIPLE Registered Establishment Name: BSN MEDICAL, INC.. |
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Classification: PROSTHESIS, KNEE, HINGED (METAL-METAL) Generic Device Name: ELASTIC HINGE KNEE BRACE Proprietary Device Name: ELASTIC HINGE KNEE BRACE Registered Establishment Name: A & A ORTHOPEDIC APPLIANCES, INC.. |
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Classification: SPLINT, TRACTION Generic Device Name: BUCK'S TRACTION Proprietary Device Name: BUCK'S TRACTION Registered Establishment Name: A & A ORTHOPEDIC APPLIANCES, INC.. |
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Classification: BELT, PELVIC, TRACTION Generic Device Name: PELVIC TRACTION SET? Proprietary Device Name: PELVIC TRACTION SET? Registered Establishment Name: A & A ORTHOPEDIC APPLIANCES, INC.. |
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Classification: APPARATUS, TRACTION, NON-POWERED Generic Device Name: ACCESSORIES, FRAME, CORD, ETCC... Proprietary Device Name: ACCESSORIES, FRAME, CORD, ETCC... Registered Establishment Name: A & A ORTHOPEDIC APPLIANCES, INC.. |
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Classification: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL Generic Device Name: VARIOUS TYPES OF HIP PROSTHESES Proprietary Device Name: MULTIPLE Registered Establishment Name: WRIGHT MEDICAL TECHNOLOGY, INC.. |
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Classification: DEVICE, FIXATION, PROXIMAL FEMORAL, IMPLANT Generic Device Name: VARIOUS INTERTROCHANTERIC FIXATION DEVICES Proprietary Device Name: MULTIPLE Registered Establishment Name: WRIGHT MEDICAL TECHNOLOGY, INC.. |
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Classification: NAIL, FIXATION, BONE Generic Device Name: VARIOUS TYPES OF NAILS Proprietary Device Name: MULTIPLE Registered Establishment Name: WRIGHT MEDICAL TECHNOLOGY, INC.. |
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Classification: CAP, BONE Generic Device Name: VARIOUS TYPES OF BONE CAPS Proprietary Device Name: MULTIPLE Registered Establishment Name: WRIGHT MEDICAL TECHNOLOGY, INC.. |
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Classification: PIN, FIXATION, THREADED Generic Device Name: NO COMMON NAME LISTED Proprietary Device Name: THREADED WIRES Registered Establishment Name: WRIGHT MEDICAL TECHNOLOGY, INC.. |
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Classification: PROSTHESIS, WRIST, 3 PART METAL-PLASTIC-METAL ARTICULATION, SEMI-CONSTRAINED Generic Device Name: TOTAL WRIST PROSTHESIS Proprietary Device Name: TULEISNIK TOTAL WRIST PROSTHESIS Registered Establishment Name: WRIGHT MEDICAL TECHNOLOGY, INC.. |
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Classification: GONIOMETER, NONPOWERED Generic Device Name: GONIOMETER Proprietary Device Name: GONIOMETER Registered Establishment Name: WRIGHT MEDICAL TECHNOLOGY, INC.. |
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Classification: COMPONENT, TRACTION, NON-INVASIVE Generic Device Name: NO COMMON NAME LISTED Proprietary Device Name: SERRATED CLIP Registered Establishment Name: WRIGHT MEDICAL TECHNOLOGY, INC.. |
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Classification: PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER Generic Device Name: NO COMMON NAME LISTED Proprietary Device Name: SMITH FENORAL PATELLA PROSTHESIS Registered Establishment Name: WRIGHT MEDICAL TECHNOLOGY, INC.. |
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Classification: CALIPER Generic Device Name: VARIOUS TYPES OF CALIPERS Proprietary Device Name: MULTIPLE Registered Establishment Name: WRIGHT MEDICAL TECHNOLOGY, INC.. |
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Classification: SCISSORS, ORTHOPEDIC, SURGICAL Generic Device Name: VARIOUS TYPES OF SCISSORS Proprietary Device Name: MULTIPLE Registered Establishment Name: WRIGHT MEDICAL TECHNOLOGY, INC.. |
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Classification: PLATE, FIXATION, BONE Generic Device Name: NO COMMON NAME LISTED Proprietary Device Name: SHELTON INSERT HOLDER Registered Establishment Name: WRIGHT MEDICAL TECHNOLOGY, INC.. |
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Classification: STRIPPER, SURGICAL Generic Device Name: VARIOUS TYPES OF SURGICAL STRIPPERS Proprietary Device Name: MULTIPLE Registered Establishment Name: WRIGHT MEDICAL TECHNOLOGY, INC.. |
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Classification: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER Generic Device Name: VARIOUS TYPES OF KNEE PROSTHESES Proprietary Device Name: MULTIPLE Registered Establishment Name: WRIGHT MEDICAL TECHNOLOGY, INC.. |
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Classification: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Generic Device Name: VARIOUS TYPES OF INTRAMEDULLARY FIXATION IMPLANTS Proprietary Device Name: MULTIPLE Registered Establishment Name: WRIGHT MEDICAL TECHNOLOGY, INC.. |
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Classification: PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER Generic Device Name: SMITH TOTAL ANKLE Proprietary Device Name: SMITH TOTAL ANKLE Registered Establishment Name: WRIGHT MEDICAL TECHNOLOGY, INC.. |
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Classification: SPLINT, TRACTION Generic Device Name: BUCKS TRACTION SPLINT Proprietary Device Name: BUCKS TRACTION SPLINT Registered Establishment Name: WRIGHT MEDICAL TECHNOLOGY, INC.. |
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Classification: BELT, PELVIC, TRACTION Generic Device Name: VARIOUS TYPES OF PELVIC TRACTION BELTS Proprietary Device Name: MULTIPLE Registered Establishment Name: WRIGHT MEDICAL TECHNOLOGY, INC.. |
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Classification: HALTER, HEAD, TRACTION Generic Device Name: HEAD HALTER Proprietary Device Name: HEAD HALTER Registered Establishment Name: WRIGHT MEDICAL TECHNOLOGY, INC.. |
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Classification: APPARATUS, TRACTION, NON-POWERED Generic Device Name: VARIOUS TYPES OF FINGER AND TOE PROSTHESES Proprietary Device Name: MULTIPLE Registered Establishment Name: WRIGHT MEDICAL TECHNOLOGY, INC.. |
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Classification: PROBE Generic Device Name: PROBE Proprietary Device Name: MULTIPLE Registered Establishment Name: WRIGHT MEDICAL TECHNOLOGY, INC.. |
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