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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: VARIOUS INTERFERENCE SCREWS AND ACCESSORIES Proprietary Device Name: MULTIPLE Registered Establishment Name: SMITH & NEPHEW, INC.. |
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Classification: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE Generic Device Name: ABSORBABLE SUTURE ANCHOR AND ACCESSORIES Proprietary Device Name: TAG BONE ANCHOR Registered Establishment Name: SMITH & NEPHEW, INC.. |
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Classification: ARTHROSCOPE Generic Device Name: VARIOUS ARTHROSCOPIC ACCESSORIES Proprietary Device Name: MULTIPLE Registered Establishment Name: SMITH & NEPHEW, INC.. |
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Classification: BIT, DRILL Generic Device Name: VARIOUS DRILL BITS Proprietary Device Name: MULTIPLE Registered Establishment Name: SMITH & NEPHEW, INC.. |
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Classification: WASHER, BOLT NUT Generic Device Name: VARIOUS Proprietary Device Name: MULTIPLE Registered Establishment Name: SMITH & NEPHEW, INC.. |
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Classification: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT Generic Device Name: VARIOUS Proprietary Device Name: MULTIPLE Registered Establishment Name: SMITH & NEPHEW, INC.. |
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Classification: PASSER Generic Device Name: VARIOUS PASSERS Proprietary Device Name: MULTIPLE Registered Establishment Name: SMITH & NEPHEW, INC.. |
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Classification: GAUGE, DEPTH Generic Device Name: VARIOUS MEASURING DEVICES Proprietary Device Name: MULTIPLE Registered Establishment Name: SMITH & NEPHEW, INC.. |
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Classification: PIN, FIXATION, SMOOTH Generic Device Name: VARIOUS PINS Proprietary Device Name: MULTIPLE Registered Establishment Name: SMITH & NEPHEW, INC.. |
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Classification: KNIFE, ORTHOPEDIC Generic Device Name: VARIOUS SURGICAL INSTRUMENTS Proprietary Device Name: MULTIPLE Registered Establishment Name: SMITH & NEPHEW, INC.. |
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Classification: STAPLE, FIXATION, BONE Generic Device Name: VARIOUS FIXATION SCREW OR ANCHORS Proprietary Device Name: MULTIPLE Registered Establishment Name: SMITH & NEPHEW, INC.. |
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Classification: PASSER, WIRE, ORTHOPEDIC Generic Device Name: VARIOUS PASSERS Proprietary Device Name: MULTIPLE Registered Establishment Name: SMITH & NEPHEW, INC.. |
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Classification: TAP, BONE Generic Device Name: VARIOUS BONE TAPS Proprietary Device Name: MULTIPLE Registered Establishment Name: SMITH & NEPHEW, INC.. |
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Classification: EXTRACTOR Generic Device Name: VARIOUS EXTRACTORS Proprietary Device Name: MULTIPLE Registered Establishment Name: SMITH & NEPHEW, INC.. |
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Classification: WRENCH Generic Device Name: VARIOUS STABILIZERS OR WRENCHES Proprietary Device Name: MULTIPLE Registered Establishment Name: SMITH & NEPHEW, INC.. |
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Classification: AWL Generic Device Name: VARIOUS AWLS Proprietary Device Name: MULTIPLE Registered Establishment Name: SMITH & NEPHEW, INC.. |
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Classification: TAMP Generic Device Name: VARIOUS TAMPS Proprietary Device Name: MULTIPLE Registered Establishment Name: SMITH & NEPHEW, INC.. |
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Classification: GUIDE, DRILL, LIGAMENT Generic Device Name: VARIOUS GUIDES Proprietary Device Name: MULTIPLE Registered Establishment Name: SMITH & NEPHEW, INC.. |
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Classification: DRIVER, PROSTHESIS Generic Device Name: VARIOUS SCREW DRIVERS Proprietary Device Name: MULTIPLE Registered Establishment Name: SMITH & NEPHEW, INC.. |
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Classification: PROSTHESIS, TOE (METATARSOPHALANGEAL), JOINT, METAL/POLYMER, SEMI-CONSTRAINED Generic Device Name: BIO-ACTION GREAT TOE IMPLANT Proprietary Device Name: GREAT TOE IMPLANT Registered Establishment Name: SMITH & NEPHEW, INC.. |
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Classification: COUNTERSINK Generic Device Name: VARIOUS SIZES OF COUNTER SINKS Proprietary Device Name: COUNTERSINK Registered Establishment Name: SMITH & NEPHEW, INC.. |
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Classification: SCREWDRIVER Generic Device Name: SCREWDRIVER Proprietary Device Name: SCREWDRIVER Registered Establishment Name: SMITH & NEPHEW, INC.. |
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Classification: INSTRUMENT, COMPRESSION Generic Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Proprietary Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Registered Establishment Name: SMITH & NEPHEW, INC.. |
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Classification: COMPONENT, CAST Generic Device Name: SYNTHETIC FIBER CAST PADDING Proprietary Device Name: SYNTHETIC FIBER CAST PADDING Registered Establishment Name: FIBERBOND CORPORATION. |
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Classification: APPARATUS, TRACTION, NON-POWERED Generic Device Name: NON-POWERED TRACTION UNIT Proprietary Device Name: NON-POWERED TRACTION UNIT Registered Establishment Name: PHYSICAL RESEARCH CO.. |
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Classification: ARTHROSCOPE Registered Establishment Name: QUESTUS CORP.. |
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Classification: COMPONENT, TRACTION, INVASIVE Generic Device Name: LIMA CIRCULAR FIXATOR Proprietary Device Name: LIMA ECS Registered Establishment Name: LIMA INTL. CORP.. |
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Classification: APPARATUS, TRACTION, NON-POWERED Generic Device Name: NONPOWERED ORTHOPEDIC TRACTION APPARATUS & ACCESSORIES Proprietary Device Name: MULTIPLE Registered Establishment Name: ALLEN MEDICAL SYSTEMS, INC.. |
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Classification: INSTRUMENT, COMPRESSION Generic Device Name: COMPRESSION DEVICE Proprietary Device Name: LYMPHAPRESS; LYMPHAPRESS MINI Registered Establishment Name: GLOBAL MEDICAL IMPORTS, INC.. |
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Classification: ARTHROSCOPE Generic Device Name: ARTHROSCOPE Proprietary Device Name: ROC SUTURE BONE FASTENER INSTRUMENT SET Registered Establishment Name: DEPUY MITEK, A JOHNSON & JOHNSON COMPANY. |
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Classification: ACCESSORIES,ARTHROSCOPIC Generic Device Name: TROCAR, STERILE AND NON-STERILE Proprietary Device Name: TROCAR Registered Establishment Name: DEPUY MITEK, A JOHNSON & JOHNSON COMPANY. |
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Classification: STAPLE, FIXATION, BONE Generic Device Name: STAPLE,FIXATION,BONE Proprietary Device Name: MULTIPLE ANCHORS Registered Establishment Name: DEPUY MITEK, A JOHNSON & JOHNSON COMPANY. |
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Classification: SCREW, FIXATION, BONE Generic Device Name: SCREW,FIXATION,BONE Proprietary Device Name: MULTIPLE Registered Establishment Name: DEPUY MITEK, A JOHNSON & JOHNSON COMPANY. |
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Classification: GAUGE, DEPTH Generic Device Name: GAUGE,DEPTH Proprietary Device Name: GAUGE Registered Establishment Name: DEPUY MITEK, A JOHNSON & JOHNSON COMPANY. |
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Classification: REAMER Generic Device Name: VARIOUS ORTHOPEDIC REAMERS Proprietary Device Name: MULTIPLE Registered Establishment Name: DEPUY MITEK, A JOHNSON & JOHNSON COMPANY. |
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Classification: KNIFE, ORTHOPEDIC Generic Device Name: KNIFE,ORTHOPEDIC Proprietary Device Name: MULTIPLE Registered Establishment Name: DEPUY MITEK, A JOHNSON & JOHNSON COMPANY. |
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Classification: BIT, DRILL Generic Device Name: BIT,DRILL Proprietary Device Name: MULTIPLE Registered Establishment Name: DEPUY MITEK, A JOHNSON & JOHNSON COMPANY. |
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Classification: EXTRACTOR Generic Device Name: EXTRACTOR AND VARIOUS TYPES OF REMOVAL TOOLS Proprietary Device Name: MULTIPLE Registered Establishment Name: DEPUY MITEK, A JOHNSON & JOHNSON COMPANY. |
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Classification: AWL Generic Device Name: VARIOUS AWLS Proprietary Device Name: MULTIPLE Registered Establishment Name: DEPUY MITEK, A JOHNSON & JOHNSON COMPANY. |
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Classification: PASSER Generic Device Name: VARIOUS SUTURE PASSERS Proprietary Device Name: MULTIPLE Registered Establishment Name: DEPUY MITEK, A JOHNSON & JOHNSON COMPANY. |
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