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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: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICUM-PHOSPHATE Generic Device Name: COATED FEMORAL COMPONENT Proprietary Device Name: LSF "HA" COATED FEMORAL COMPONENT Registered Establishment Name: ENCORE MEDICAL - HUNT VALLEY. |
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Classification: SCREWDRIVER Generic Device Name: UNIVERSAL JOINT SCREWDRIVER Proprietary Device Name: UNIVERSAL JOINT SCREWDRIVER Registered Establishment Name: ENCORE MEDICAL - HUNT VALLEY. |
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Classification: DRIVER, PROSTHESIS Generic Device Name: PROSTHESIS IMPACTOR Proprietary Device Name: MULTIPLE (PROSTHESIS IMPACTOR) Registered Establishment Name: ENCORE MEDICAL - HUNT VALLEY. |
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Classification: CERCLAGE, FIXATION Generic Device Name: ORTHOPEDIC WIRE SYSTEM/VARIOUS WIRES Proprietary Device Name: OTI ORTHOPEDIC WIRE SYSTEM Registered Establishment Name: ENCORE MEDICAL - HUNT VALLEY. |
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Classification: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Generic Device Name: INTRAMEDULLARY ROD SYSTEM Proprietary Device Name: MODIFIED ZICKEL INTRAMEDULLARY ROD Registered Establishment Name: ENCORE MEDICAL - HUNT VALLEY. |
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Classification: ORTHOSIS, SPONDYLOISTHESIS SPINAL FIXATION Generic Device Name: VARIOUS SPONDYLOISTHESIS SPINAL FIXATION ORTHOSIS Proprietary Device Name: MULTIPLE Registered Establishment Name: ENCORE MEDICAL - HUNT VALLEY. |
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Classification: APPLIANCE, FIXATION, SPINAL INTERLAMINAL Generic Device Name: VARIOUS SPINAL APPLIANCES Proprietary Device Name: MULTIPLE Registered Establishment Name: ENCORE MEDICAL - HUNT VALLEY. |
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Classification: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Generic Device Name: ORTHOPEDIC SURGICAL INSTRUMENT SET Proprietary Device Name: MULTIPLE Registered Establishment Name: OSTEOTECH, INC.. |
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Classification: TEMPLATE Generic Device Name: TEMPLATE Proprietary Device Name: MULTIPLE Registered Establishment Name: OSTEOTECH, INC.. |
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Classification: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE Generic Device Name: VERTEBRAL BODY REPLACEMENT DEVICES Proprietary Device Name: GRAFTCAGE TLX, GRAFTCAGE ACX Registered Establishment Name: OSTEOTECH, INC.. |
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Classification: FILLER, BONE VOID, CALCIUM COMPOUND Generic Device Name: DBM BONE GRAFTING MATERIALS Proprietary Device Name: GRAFTON DBM,GRAFTON PLUS DBM, VIAGRAF DBM Registered Establishment Name: OSTEOTECH, INC.. |
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Classification: SCISSORS, ORTHOPEDIC, SURGICAL Generic Device Name: SCISSORS Registered Establishment Name: HENRY SCHEIN, INC.. |
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Classification: TEMPLATE Generic Device Name: X-RAY MARKER Proprietary Device Name: E-Z MARK & E-Z GRID Registered Establishment Name: E-Z-EM, INC.. |
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Classification: AWL Generic Device Name: AWLS, ORTHOPEDIC Proprietary Device Name: PRESBYTERIAN Registered Establishment Name: GEORGE TIEMANN & CO.. |
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Classification: SCISSORS, ORTHOPEDIC, SURGICAL Generic Device Name: ROSENBLATT Proprietary Device Name: ROSENBLATT Registered Establishment Name: GEORGE TIEMANN & CO.. |
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Classification: IMPACTOR Generic Device Name: HIBBS Proprietary Device Name: HIBBS Registered Establishment Name: GEORGE TIEMANN & CO.. |
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Classification: EVACUATOR, VAPOR, CEMENT MONOMER Generic Device Name: ELECTROSURGICAL/LASER SMOKE PLUME EVACUATOR Proprietary Device Name: VAPOR-VAC, VAPOR VAC II Registered Establishment Name: ELLMAN INT'L INC.. |
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Classification: GONIOMETER, NONPOWERED Generic Device Name: RADIPAQUE GONIOMETER Proprietary Device Name: RADIPAQUE GONIOMETER Registered Establishment Name: GF HEALTH PRODUCTS, INC. |
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Classification: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Generic Device Name: VARIOUS MANUAL SURGICAL INSTRUMENTS Proprietary Device Name: MULTIPLE Registered Establishment Name: J. JAMNER SURGICAL INSTRUMENTS, INC.. |
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Classification: GONIOMETER, NONPOWERED Generic Device Name: NON-POWERED GONIOMETER Proprietary Device Name: BASELINE GONIOMETER Registered Establishment Name: FABRICATION ENT., INC.. |
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Classification: DYNAMOMETER, NONPOWERED Generic Device Name: NON-POWERED DYNAMOMETER Proprietary Device Name: VARIOUS NON-POWERED DYNAMOMETER Registered Establishment Name: FABRICATION ENT., INC.. |
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Classification: SCISSORS, ORTHOPEDIC, SURGICAL Generic Device Name: SCISSORS, BANDAGE/GAUZE/PLASTER Registered Establishment Name: FINE SURGICAL, INC.. |
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Classification: GONIOMETER, NONPOWERED Generic Device Name: DELUXE GULCK SPRING Proprietary Device Name: BASELINE Registered Establishment Name: JIMCO INDUSTRIES. |
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Classification: AWL Generic Device Name: VARIOUS TYPES OF AWLS Proprietary Device Name: MULTIPLE Registered Establishment Name: KMEDIC, TELEFLEX MEDICAL. |
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Classification: BENDER Generic Device Name: ROD BENDER Proprietary Device Name: MULTIPLE Registered Establishment Name: KMEDIC, TELEFLEX MEDICAL. |
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Classification: BIT, DRILL Generic Device Name: VARIOUS TYPES OF DRILL BITS Proprietary Device Name: DRILL BIT Registered Establishment Name: KMEDIC, TELEFLEX MEDICAL. |
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Classification: COUNTERSINK Generic Device Name: VARIOUS TYPES OF COUNTERSINKS Proprietary Device Name: MULTIPLE Registered Establishment Name: KMEDIC, TELEFLEX MEDICAL. |
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Classification: CUTTER, WIRE Generic Device Name: VARIOUS TYPES OF CUTTERS Proprietary Device Name: MULTIPLE Registered Establishment Name: KMEDIC, TELEFLEX MEDICAL. |
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Classification: GAUGE, DEPTH Generic Device Name: VARIOUS TYPES OF DEPTH GAUGES Proprietary Device Name: MULTIPLE Registered Establishment Name: KMEDIC, TELEFLEX MEDICAL. |
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Classification: HOLDER, NEEDLE; ORTHOPEDIC Generic Device Name: VARIOUS TYPES OF HOLDERS Proprietary Device Name: MULTIPLE Registered Establishment Name: KMEDIC, TELEFLEX MEDICAL. |
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Classification: RONGEUR Generic Device Name: VARIOUS TYPES OF RONGEURS Proprietary Device Name: MULTIPLE Registered Establishment Name: KMEDIC, TELEFLEX MEDICAL. |
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Classification: SCISSORS, ORTHOPEDIC, SURGICAL Generic Device Name: VARIOUS TYPES OF SCISSORS Proprietary Device Name: MULTIPLE Registered Establishment Name: KMEDIC, TELEFLEX MEDICAL. |
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Classification: SCREWDRIVER Generic Device Name: VARIOUS TYPES OF SCREWDRIVERS Proprietary Device Name: MULTIPLE Registered Establishment Name: KMEDIC, TELEFLEX MEDICAL. |
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Classification: TAMP Generic Device Name: VARIOUS TYPES OF TAMPS Proprietary Device Name: MULTIPLE Registered Establishment Name: KMEDIC, TELEFLEX MEDICAL. |
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Classification: TAP, BONE Generic Device Name: VARIOUS TYPES OF TAPS Proprietary Device Name: MULTIPLE Registered Establishment Name: KMEDIC, TELEFLEX MEDICAL. |
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Classification: TREPHINE Generic Device Name: VARIOUS TYPES OF TREPHINES Proprietary Device Name: MULTIPLE Registered Establishment Name: KMEDIC, TELEFLEX MEDICAL. |
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Classification: TWISTER, WIRE Generic Device Name: VARIOUS TYPES OF TWISTERS Proprietary Device Name: MULTIPLE Registered Establishment Name: KMEDIC, TELEFLEX MEDICAL. |
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Classification: WIRE, SURGICAL Generic Device Name: VARIOUS TYPES OF WIRES Proprietary Device Name: MULTIPLE Registered Establishment Name: KMEDIC, TELEFLEX MEDICAL. |
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Classification: PASSER Generic Device Name: VARIOUS TYPES OF PASSERS Proprietary Device Name: MULTIPLE Registered Establishment Name: KMEDIC, TELEFLEX MEDICAL. |
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Classification: PROBE Generic Device Name: VARIOUS TYPES OF PROBES Proprietary Device Name: MULTIPLE Registered Establishment Name: KMEDIC, TELEFLEX MEDICAL. |
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