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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: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Generic Device Name: SURGICAL INSTRUMENTS Proprietary Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Registered Establishment Name: WRIGHT MEDICAL TECHNOLOGY, INC.. |
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Classification: BIT, DRILL Generic Device Name: SURGICAL INSTRUMENTS Proprietary Device Name: DRILL BIT Registered Establishment Name: WRIGHT MEDICAL TECHNOLOGY, INC.. |
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Classification: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE Generic Device Name: SOFT TISSUE ANCHOR SYSTEM Proprietary Device Name: QUESTUS POLYESTER SOFT TISSYE ANCHOR SYSTEM Registered Establishment Name: WRIGHT MEDICAL TECHNOLOGY, INC.. |
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Classification: ORTHOSIS, SPONDYLOISTHESIS SPINAL FIXATION Generic Device Name: SPINAL FIXATION DEVICE Proprietary Device Name: WRIGHTLOCK POSTERIOR SPINAL FIXATION DEVICE Registered Establishment Name: WRIGHT MEDICAL TECHNOLOGY, INC.. |
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Classification: PROSTHESIS, HIP, FEMORAL, RESURFACING Generic Device Name: RESURFACING FEMORAL COMPONENT Proprietary Device Name: ORTHOMET RESURFACING FEMORAL COMPONENT Registered Establishment Name: WRIGHT MEDICAL TECHNOLOGY, INC.. |
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Classification: PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED Generic Device Name: TOTAL SHOULDER PROTHESIS Proprietary Device Name: INFINITY TOTAL SHOULDER SYSTEM Registered Establishment Name: WRIGHT MEDICAL TECHNOLOGY, INC.. |
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Classification: PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER Generic Device Name: METALLIC RADIAL HEAD Proprietary Device Name: METALLIC RADIAL HEAD IMPLANTS Registered Establishment Name: WRIGHT MEDICAL TECHNOLOGY, INC.. |
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Classification: FILLER, BONE VOID, CALCIUM COMPOUND Generic Device Name: WRIGHT PLASTER OF PARIS PELLETS Proprietary Device Name: WRIGHT PLASTER OF PARIS PELLETS Registered Establishment Name: WRIGHT MEDICAL TECHNOLOGY, INC.. |
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Classification: APPLIANCE, FIXATION, SPINAL INTERLAMINAL Generic Device Name: ROD-TO-ROD COUPLER Proprietary Device Name: WRIGHT MEDICAL TECHNOLOGY ROD-TO-ROD COUPLER Registered Establishment Name: WRIGHT MEDICAL TECHNOLOGY, INC.. |
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Classification: PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED Generic Device Name: ELBOW PROSTHESIS Proprietary Device Name: ELBOW PROSTHESIS Registered Establishment Name: WRIGHT MEDICAL TECHNOLOGY, INC.. |
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Classification: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER Generic Device Name: ROTATING HINGE KNEE Proprietary Device Name: ROTATING HINGE KNEE Registered Establishment Name: WRIGHT MEDICAL TECHNOLOGY, INC.. |
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Classification: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER Generic Device Name: TOTAL KNEE SYSTEM Proprietary Device Name: TOTAL KNEE SYSTEM Registered Establishment Name: WRIGHT MEDICAL TECHNOLOGY, INC.. |
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Classification: SCREW, FIXATION, BONE Generic Device Name: SMOOTH OR THREADED METALLIC BONE FIXATION FASTENER Proprietary Device Name: SMOOTH OR THREADED METALLIC BONE FIXATION FASTENER Registered Establishment Name: WRIGHT MEDICAL TECHNOLOGY, INC.. |
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Classification: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED Generic Device Name: HIP SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED Proprietary Device Name: HIP SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED Registered Establishment Name: WRIGHT MEDICAL TECHNOLOGY, INC.. |
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Classification: PROSTHESIS, WRIST, HEMI-, ULNAR Generic Device Name: WRIST JOINT ULNAR (HEMI-WRIST) POLYMER PROSTHESIS Proprietary Device Name: WRIST JOINT ULNAR (HEMI-WRIST) POLYMER PROSTHESIS Registered Establishment Name: WRIGHT MEDICAL TECHNOLOGY, INC.. |
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Classification: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED Generic Device Name: SHOULDER JOINT METAL/POLYMER SEMI-CONSTRAINED CEMENTED Proprietary Device Name: SHOULDER JOINT METAL/POLYMER SEMI-CONSTRAINED CEMENTED Registered Establishment Name: WRIGHT MEDICAL TECHNOLOGY, INC.. |
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Classification: PROSTHESIS, HIP, SEMI-CONSTRAINED (METAL CEMENTED ACETABULAR COMPONENT) Generic Device Name: HIP JOINT METAL/METAL SEMI-CONSTRAINED, WITH A CEMENTED ACETABULAR COMPONENT Proprietary Device Name: HIP JOINT METAL/METAL SEMI-CONSTRAINED, WITH A CEMENTED ACETABULAR COMPONENT Registered Establishment Name: WRIGHT MEDICAL TECHNOLOGY, INC.. |
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Classification: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED Generic Device Name: HIP JOINT METAL/POLYMER/METAL SEMI-CONSTRAINED POROUS-COATED UNCEMENTED PROSTHES Proprietary Device Name: HIP JOINT METAL/POLYMER/METAL SEMI-CONSTRAINED POROUS-COATED UNCEMENTED PROSTHES Registered Establishment Name: WRIGHT MEDICAL TECHNOLOGY, INC.. |
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Classification: PROSTHESIS, TENDON, PASSIVE Generic Device Name: TENDON Proprietary Device Name: HUNTER TENDON Registered Establishment Name: WRIGHT MEDICAL TECHNOLOGY, INC.. |
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Classification: BIT, DRILL Generic Device Name: VARIOUS MEDICAL DRILL BITS Registered Establishment Name: MICROTEK MEDICAL, INC.. |
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Classification: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Generic Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENTS Proprietary Device Name: ORTHOPLAST Registered Establishment Name: MICROTEK MEDICAL, INC.. |
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Classification: SPLINT, TRACTION Generic Device Name: PELVIC TRACTION BELT, KNEE SLING Proprietary Device Name: NONE Registered Establishment Name: FLA. ORTHOPEDICS, INC.. |
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Classification: HALTER, HEAD, TRACTION Generic Device Name: HEAD HALTER, CERVICAL TRACTION Proprietary Device Name: NONE Registered Establishment Name: FLA. ORTHOPEDICS, INC.. |
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Classification: BELT, PELVIC, TRACTION Generic Device Name: PELVIC TRACTION BELT VARIOUS TYPES Proprietary Device Name: NONE Registered Establishment Name: FLA. ORTHOPEDICS, INC.. |
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Classification: APPARATUS, TRACTION, NON-POWERED Generic Device Name: CERVICAL TRACTION UNIT, OVER-THE-D00R TRACTION, PELVIC TRACTION UNIT Proprietary Device Name: NONE Registered Establishment Name: FLA. ORTHOPEDICS, INC.. |
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Classification: PLATE, FIXATION, BONE Generic Device Name: PLATE, BONE Proprietary Device Name: PLATE, BONE Registered Establishment Name: BIO-LOK INTL., INC.. |
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Classification: PROSTHESIS, KNEE, HINGED (METAL-METAL) Generic Device Name: KNEE, PROSTHESES, KNEE HINGED (METAL-METAL) Proprietary Device Name: KNEE, PROSTHESES, KNEE HINGED (METAL-METAL) Registered Establishment Name: BIO-LOK INTL., INC.. |
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Classification: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Generic Device Name: MULTIPLE Proprietary Device Name: MULTIPLE Registered Establishment Name: BIO-LOK INTL., INC.. |
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Classification: PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER Generic Device Name: ANKLE,PROSTHESIS, ANKLE, 2 PART METAL ON PLASTIC ARTI Proprietary Device Name: ANKLE,PROSTHESIS, ANKLE, 2 PART METAL ON PLASTIC ARTI Registered Establishment Name: BIO-LOK INTL., INC.. |
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Classification: GAUGE, DEPTH Generic Device Name: ORTHOPEDIC, GAUGE DEPTH Proprietary Device Name: ORTHOPEDIC, GAUGE DEPTH Registered Establishment Name: BIO-LOK INTL., INC.. |
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Classification: WASHER, BOLT NUT Generic Device Name: NUTS, BOLTS, NUTS, WASHERS Proprietary Device Name: NUTS, BOLTS, NUTS, WASHERS Registered Establishment Name: BIO-LOK INTL., INC.. |
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Classification: SCREW, FIXATION, BONE Generic Device Name: BONE, SCREW, BONE Proprietary Device Name: BONE, SCREW, BONE Registered Establishment Name: BIO-LOK INTL., INC.. |
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Classification: STARTER, BONE SCREW Generic Device Name: STARTER, BONE SCREW, ORTHOPEDIC Proprietary Device Name: STARTER, BONE SCREW, ORTHOPEDIC Registered Establishment Name: BIO-LOK INTL., INC.. |
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Classification: TEMPLATE Generic Device Name: CUTTING,TEMPLATE,FEMORAL ANGLE CUTTING Proprietary Device Name: CUTTING,TEMPLATE,FEMORAL ANGLE CUTTING Registered Establishment Name: BIO-LOK INTL., INC.. |
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Classification: INSTRUMENT, BENDING OR CONTOURING Generic Device Name: BENDING, INSTRUMENT, BENDING OR CONTOURING, ORTHOPEDIC Proprietary Device Name: BENDING, INSTRUMENT, BENDING OR CONTOURING, ORTHOPEDIC Registered Establishment Name: BIO-LOK INTL., INC.. |
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Classification: CRIMPER, PIN Generic Device Name: MULTIPLE Proprietary Device Name: MULTIPLE Registered Establishment Name: BIO-LOK INTL., INC.. |
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Classification: SCREWDRIVER Generic Device Name: ORTHOPEDIC, SCREWDRIVER Proprietary Device Name: ORTHOPEDIC, SCREWDRIVER Registered Establishment Name: BIO-LOK INTL., INC.. |
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Classification: PROSTHESIS, UPPER FEMORAL Generic Device Name: MULTIPLE Proprietary Device Name: MULTIPLE Registered Establishment Name: BIO-LOK INTL., INC.. |
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Classification: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL Generic Device Name: CEMENTED, PROSTHESIS,HIP,FEMORAL COMPONENT Proprietary Device Name: CEMENTED, PROSTHESIS,HIP,FEMORAL COMPONENT Registered Establishment Name: BIO-LOK INTL., INC.. |
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Classification: PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL Generic Device Name: BEARING PROSTHESIS, HIP, 4 PART PLASTIC METAL-METAL, TRUNNION BEARING TYPE Proprietary Device Name: BEARING PROSTHESIS, HIP, 4 PART PLASTIC METAL-METAL, TRUNNIO Registered Establishment Name: BIO-LOK INTL., INC.. |
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