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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: TAMP Generic Device Name: ACETABULAR, RESTRICTOR TRIAL /TAMP Proprietary Device Name: MULTIPLE Registered Establishment Name: ZIMMER TRABECULAR. |
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Classification: WRENCH Generic Device Name: CROSS BAR HANDLE Proprietary Device Name: MULTIPLE Registered Establishment Name: ZIMMER TRABECULAR. |
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Classification: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED Generic Device Name: SHOULDER DEVICES Proprietary Device Name: SHOULDER DEVICES Registered Establishment Name: ZIMMER TRABECULAR. |
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Classification: PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED Generic Device Name: SHOULDER DEVICES Proprietary Device Name: SHOULDER DEVICES Registered Establishment Name: ZIMMER TRABECULAR. |
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Classification: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER Generic Device Name: TRABECULAR METAL KNEE SYSTEM AUGMENT Proprietary Device Name: TRABECULAR METAL KNEE SYSTEM AUGMENT Registered Establishment Name: ZIMMER TRABECULAR. |
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Classification: CAP, BONE Generic Device Name: CAP, BONE Proprietary Device Name: CAP, BONE Registered Establishment Name: POREX SURGICAL, INC.. |
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Classification: PIN, FIXATION, THREADED Generic Device Name: KIRSHNER WIRES (K-WIRE) & STEINMANN PINS Proprietary Device Name: KIRSHNER WIRES (K-WIRE) & STEINMANN PINS Registered Establishment Name: PROMEX TECHNOLOGIES, LLC. |
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Classification: SCISSORS, ORTHOPEDIC, SURGICAL Generic Device Name: SCISSORS Proprietary Device Name: N.S. SURGICAL CO. Registered Establishment Name: N.S. SURGICAL CO.. |
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Classification: INSTRUMENT, SURGICAL, ORTHOPEDIC, PNEUMATIC POWERED & ACCESSORY/ATTACHMENT Generic Device Name: ORTHOPEDIC INSTRUMENT Proprietary Device Name: BAUMER SURGICAL INSTRUMENTS Registered Establishment Name: BAUMER S.A.. |
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Classification: PLATE, FIXATION, BONE Generic Device Name: VARIOUS MODELS OF PLATES Proprietary Device Name: BAUMER PLATES Registered Establishment Name: BAUMER S.A.. |
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Classification: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Generic Device Name: VARIOUS MODELS OF INTRMEDULLARY SYSTEMS Proprietary Device Name: BAUMER INTRAMEDULLARY SYSTEMS Registered Establishment Name: BAUMER S.A.. |
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Classification: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED Generic Device Name: VARIOUS MODELS OF FEMORAL HEADS Proprietary Device Name: BAUMER FEMORAL HEAD Registered Establishment Name: BAUMER S.A.. |
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Classification: SCREW, FIXATION, BONE Generic Device Name: VARIOUS MODELS OF SCREWS Proprietary Device Name: BAUMER SCREWS Registered Establishment Name: BAUMER S.A.. |
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Classification: STAPLE, FIXATION, BONE Generic Device Name: VARIOUS MODELS OF STAPLES Proprietary Device Name: BAUMER STAPLES Registered Establishment Name: BAUMER S.A.. |
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Classification: PIN, FIXATION, SMOOTH Generic Device Name: VARIOUS MODELS OF PINS Proprietary Device Name: BAUMER PINS Registered Establishment Name: BAUMER S.A.. |
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Classification: PROSTHESIS, HIP, SEMI-CONSTRAINED (METAL UNCEMENTED ACETABULAR COMPONENT) Generic Device Name: BAUMER FEMORAL HEAD Proprietary Device Name: BAUMER FEMORAL HEAD Registered Establishment Name: BAUMER S.A.. |
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Classification: HALTER, HEAD, TRACTION Generic Device Name: HEAD HALTER Proprietary Device Name: HEAD HALTER Registered Establishment Name: AMERICAN ORTHOPEDIC SUPPLY CO., INC.. |
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Classification: BELT, PELVIC, TRACTION Generic Device Name: PELVIC BELT Proprietary Device Name: PELVIC BELT Registered Establishment Name: AMERICAN ORTHOPEDIC SUPPLY CO., INC.. |
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Classification: APPARATUS, TRACTION, NON-POWERED Generic Device Name: SHOULDER SUSPENSION SYSTEM Proprietary Device Name: PROMEDICA SHOULDER SUSPENSION SYSTEM Registered Establishment Name: PROMEDICA, INC.. |
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Classification: INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR AND ACCESSORY/ATTACHMENT Generic Device Name: BATTERY, RECHARGEABLE Proprietary Device Name: MULTIPLE Registered Establishment Name: R & D BATTERIES, INC.. |
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Classification: CUTTER, WIRE Generic Device Name: WIRE CUTTER Proprietary Device Name: CUTTER, WIRE Registered Establishment Name: ALLEN SURGICAL CO, (PVT) LTD.. |
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Classification: RONGEUR Generic Device Name: VARIOUS BONE RONGEURS Proprietary Device Name: BONE RONGEUR Registered Establishment Name: ALLEN SURGICAL CO, (PVT) LTD.. |
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Classification: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POLYMER/METAL/POLYMER, OSTEOPHILIC FINISH Generic Device Name: PASSIVE ORTHOPEDIC IMPLANT- VARIOUS SIZES FOOT IMPLANTS Proprietary Device Name: SUBTALAR MBA )MAXWELL BRANCHEAU ANTHRORESIS) IMPLANT Registered Establishment Name: KINETIKOS MEDICAL, INC.. |
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Classification: PROSTHESIS, WRIST, CARPAL SCAPHOID Generic Device Name: PASSIVE ORTHOPEDIC IMPLANT (WRIST) Proprietary Device Name: WRIST FUSION SYSTEM Registered Establishment Name: KINETIKOS MEDICAL, INC.. |
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Classification: PROSTHESIS, WRIST, 3 PART METAL-PLASTIC-METAL ARTICULATION, SEMI-CONSTRAINED Generic Device Name: PASSIVE ORTHOPEDIC IMPLANT (WRIST) Proprietary Device Name: UNIVERSAL TOTAL WRIST SYSTEM Registered Establishment Name: KINETIKOS MEDICAL, INC.. |
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Classification: PROSTHESIS, TOE (METATARSOPHALANGEAL), JOINT, METAL/POLYMER, SEMI-CONSTRAINED Generic Device Name: PASSIVE ORTHOPEDIC IMPLANT (FOOT) Proprietary Device Name: KINETIC GREAT TOE IMPLANT Registered Establishment Name: KINETIKOS MEDICAL, INC.. |
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Classification: PROSTHESIS, TOE, HEMI-, PHALANGEAL Generic Device Name: PASSIVE ORTHOPEDIC IMPLANT (TOE) Proprietary Device Name: K2 HEMI TOE IMPLANT SYSTEM Registered Establishment Name: KINETIKOS MEDICAL, INC.. |
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Classification: PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER Generic Device Name: PASSIVE ORTHOPEDIC IMPLANT, ELBOW Proprietary Device Name: KATALYST RADIAL HEAD IMPLANT Registered Establishment Name: KINETIKOS MEDICAL, INC.. |
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Classification: PLATE, FIXATION, BONE Generic Device Name: PASSIVE ORTHOPEDIC IMPLANT (ARM) Proprietary Device Name: KMI DISTAL VOLAR RADIUS PLATE SYSTEM Registered Establishment Name: KINETIKOS MEDICAL, INC.. |
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Classification: SCREW, FIXATION, BONE Generic Device Name: SUBTALAR ARTHROESIS Proprietary Device Name: MBA RESORB IMPLANT Registered Establishment Name: KINETIKOS MEDICAL, INC.. |
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Classification: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY Generic Device Name: KANEDA ANTERIOR SPINAL INSTRUMENTATION SYSTEM Proprietary Device Name: KANEDA ANTERIOR SPINAL INSTRUMENTATION SYSTEM Registered Establishment Name: MIZUHO IKAKOGYO CO.. |
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Classification: CUTTER, WIRE Generic Device Name: VARIOUS Proprietary Device Name: MULTIPLE Registered Establishment Name: CHIFA SP.Z O.O.. |
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Classification: INSTRUMENT, CAST APPLICATION/REMOVAL, MANUAL Generic Device Name: VARIOUS Proprietary Device Name: MULTIPLE Registered Establishment Name: CHIFA SP.Z O.O.. |
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Classification: PROBE Generic Device Name: PROBE Proprietary Device Name: ARTHREX PROBE Registered Establishment Name: ARTHREX CALIFORNIA, INC.. |
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Classification: PASSER Generic Device Name: SUTURE RETRIVER/PASSER Proprietary Device Name: ARTHREX SUTURE RETRIVER/PASSER Registered Establishment Name: ARTHREX CALIFORNIA, INC.. |
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Classification: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Generic Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Proprietary Device Name: ARTHREX ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Registered Establishment Name: ARTHREX CALIFORNIA, INC.. |
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Classification: SCISSORS, ORTHOPEDIC, SURGICAL Generic Device Name: SCISSORS Proprietary Device Name: ARTHREX SCISSORS Registered Establishment Name: ARTHREX CALIFORNIA, INC.. |
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Classification: PROSTHESIS, HIP, SEMI-CONSTRAINED (METAL UNCEMENTED ACETABULAR COMPONENT) Generic Device Name: ARTIFICIAL HIP REPLACEMENT SYSTEM Proprietary Device Name: MULTIPLE Registered Establishment Name: STELKAST COMPANY. |
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Classification: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL Generic Device Name: ARTIFICIAL HIP REPLACEMENT SYSTEM Proprietary Device Name: MULTIPLE Registered Establishment Name: STELKAST COMPANY. |
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Classification: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED Generic Device Name: ARTIFICIAL HIP REPLACEMENT COMPONENTS Proprietary Device Name: MULTIPLE Registered Establishment Name: STELKAST COMPANY. |
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