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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: DISPENSER, CEMENT Generic Device Name: CEMENT DISPENSER Proprietary Device Name: MULTIPLE Registered Establishment Name: SYNTHES (USA). |
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Classification: MIXER, CEMENT, FOR CLINICAL USE Generic Device Name: CEMENT MIXER Proprietary Device Name: MULTIPLE Registered Establishment Name: SYNTHES (USA). |
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Classification: FILLER, BONE VOID, CALCIUM COMPOUND Generic Device Name: BONE VOID FILLER Proprietary Device Name: MULTIPLE Registered Establishment Name: SYNTHES (USA). |
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Classification: STAPLE, FIXATION, BONE Generic Device Name: BONE FIXATION STAPLE Proprietary Device Name: BIEDENMANN MOTEH MOTULAR SAGMEATEL SPIN,SYSTEM&OUTHOP. MESH Registered Establishment Name: FALCON MED INC.. |
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Classification: SCREW, FIXATION, BONE Generic Device Name: BONE FIXATION SCREW Proprietary Device Name: BIEDENMANN MOTEH MOTULAR SAGMEATEL SPIN,SYSTEM&OUTHOP. MESH Registered Establishment Name: FALCON MED INC.. |
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Classification: PLATE, FIXATION, BONE Generic Device Name: BONE FIXATION PLATE Proprietary Device Name: BIEDENMANN MOTEH MOTULAR SAGMEATEL SPIN,SYSTEM&OUTHOP. MESH Registered Establishment Name: FALCON MED INC.. |
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Classification: ORTHOSIS, FIXATION, SPINAL CERVICAL INTERVERTEBRAL BODY Generic Device Name: OSS, OSS II Proprietary Device Name: OREGON SPINE SPLINT II Registered Establishment Name: SKEDCO, INC.. |
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Classification: ARTHROSCOPE Generic Device Name: 2600 SERIES, WORKING CHANNEL ENDOSCOPE Proprietary Device Name: PEVCSCOPE Registered Establishment Name: CLARUS MEDICAL, LLC.. |
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Classification: INSTRUMENT, SURGICAL, ORTHOPEDIC, PNEUMATIC POWERED & ACCESSORY/ATTACHMENT Generic Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, PNEUMATIC POWERED & ACCESSORY Proprietary Device Name: MULTIPLE Registered Establishment Name: CLARUS MEDICAL, LLC.. |
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Classification: SCREWDRIVER Generic Device Name: SCREWDRIVER Proprietary Device Name: SCREWDRIVER Registered Establishment Name: S.S. WHITE MEDICAL PRODUCTS, INC.. |
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Classification: PUSHER, SOCKET Generic Device Name: PUSHER, SOCKET Proprietary Device Name: PUSHER, SOCKET Registered Establishment Name: S.S. WHITE MEDICAL PRODUCTS, INC.. |
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Classification: WRENCH Generic Device Name: WRENCH Proprietary Device Name: WRENCH Registered Establishment Name: S.S. WHITE MEDICAL PRODUCTS, INC.. |
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Classification: BIT, DRILL Generic Device Name: BIT, DRILL Proprietary Device Name: BIT, DRILL Registered Establishment Name: S.S. WHITE MEDICAL PRODUCTS, INC.. |
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Classification: EXTRACTOR Generic Device Name: EXTRACTOR Proprietary Device Name: EXTRACTOR Registered Establishment Name: S.S. WHITE MEDICAL PRODUCTS, INC.. |
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Classification: INSTRUMENT, COMPRESSION Generic Device Name: INSTRUMENT COMPRESSTON Proprietary Device Name: COMPRESSRON PADDLE Registered Establishment Name: BT MEDICAL CO., INC.. |
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Classification: ARTHROSCOPE Generic Device Name: DISTRACTOR Proprietary Device Name: ARTHODISTRACTOR Registered Establishment Name: ARTHROPLASTICS, INC.. |
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Classification: GONIOMETER, NONPOWERED Generic Device Name: VARIOUS TYPES OF GONIOMETER Proprietary Device Name: MULTIPLE Registered Establishment Name: NORTH COAST MEDICAL, INC.. |
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Classification: APPARATUS, TRACTION, NON-POWERED Generic Device Name: TRACTION KIT Proprietary Device Name: MULTIPLE Registered Establishment Name: NORTH COAST MEDICAL, INC.. |
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Classification: GAUGE, DEPTH Generic Device Name: VOLUMETER Proprietary Device Name: MULTIPLE Registered Establishment Name: NORTH COAST MEDICAL, INC.. |
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Classification: DYNAMOMETER, NONPOWERED Generic Device Name: VARIOUS TYPES OF DYNAMOMETERS Proprietary Device Name: MULTIPLE Registered Establishment Name: NORTH COAST MEDICAL, INC.. |
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Classification: SCISSORS, ORTHOPEDIC, SURGICAL Generic Device Name: BANDAGE SCISSORS Registered Establishment Name: POCKET NURSE ENT., INC.. |
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Classification: PROSTHESIS, TOE (METATARSOPHALANGEAL), JOINT, METAL/POLYMER, SEMI-CONSTRAINED Generic Device Name: VARIOUS SIZES OF TOE PROSTHESIS Proprietary Device Name: REFLEXION 1ST MPJ IMPLANT SYSTEM Registered Establishment Name: OSTEOMED L.P.. |
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Classification: PLATE, FIXATION, BONE Generic Device Name: VARIOUS TYPES AND SIZES OF BONE PLATES Proprietary Device Name: MULTIPLE Registered Establishment Name: OSTEOMED L.P.. |
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Classification: GAUGE, DEPTH Generic Device Name: VARIOUS TYPES AND SIZES OF DEPTH GAUGES Proprietary Device Name: MULTIPLE Registered Establishment Name: OSTEOMED L.P.. |
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Classification: BIT, DRILL Generic Device Name: VARIOUS TYPES AND SIZES OF MANUAL DRILLS Proprietary Device Name: MULTIPLE Registered Establishment Name: OSTEOMED L.P.. |
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Classification: SCREW, FIXATION, BONE Generic Device Name: VARIOUS TYPES AND SIZES OF BONE SCREWS Proprietary Device Name: MULTIPLE Registered Establishment Name: OSTEOMED L.P.. |
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Classification: TEMPLATE Generic Device Name: VARIOUS TYPES AND SIZES OF POSITION PLATES Proprietary Device Name: MULTIPLE Registered Establishment Name: OSTEOMED L.P.. |
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Classification: COUNTERSINK Generic Device Name: VARIOUS TYPES AND SIZES OF COUNTERSINKS Proprietary Device Name: MULTIPLE Registered Establishment Name: OSTEOMED L.P.. |
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Classification: TAP, BONE Generic Device Name: VARIOUS TYPES AND SIZES OF BONE TAPS Proprietary Device Name: MULTIPLE Registered Establishment Name: OSTEOMED L.P.. |
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Classification: BENDER Generic Device Name: VARIOUS TYPES AND SIZES OF PLATE BENDERS Proprietary Device Name: MULTIPLE Registered Establishment Name: OSTEOMED L.P.. |
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Classification: SCREWDRIVER Generic Device Name: VARIOUS TYPES AND SIZES OF DRIVER INSTRUMENTATION Proprietary Device Name: MULTIPLE Registered Establishment Name: OSTEOMED L.P.. |
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Classification: CUTTER, WIRE Generic Device Name: VARIOUS WIRE CUTTERS AND PLATE CUTTERS Proprietary Device Name: MULTIPLE Registered Establishment Name: OSTEOMED L.P.. |
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Classification: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT Generic Device Name: BONE HARVESTER & BONE COLLECTOR, VARIOUS Proprietary Device Name: OSTEOHARVESTER BONE HARVESTER & BONE COLLECTOR Registered Establishment Name: OSTEOMED L.P.. |
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Classification: PROSTHESIS, TOE, CONSTRAINED, POLYMER Generic Device Name: VARIOUS SIZES OF SILICONE TOE IMPLANTS Proprietary Device Name: INTERPHLEX FLEXIBLE STABILIZATION RODS Registered Establishment Name: OSTEOMED L.P.. |
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Classification: REAMER Generic Device Name: SURGICAL OR PROSTHETIC INSTRUMENT Proprietary Device Name: REAMER Registered Establishment Name: NOBEL BIOCARE USA LLC. |
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Classification: IMPACTOR Generic Device Name: SURGICAL INSTRUMENT Proprietary Device Name: IMPACTOR Registered Establishment Name: NOBEL BIOCARE USA LLC. |
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Classification: WRENCH Generic Device Name: SURGICAL OR PROSTHETIC INSTRUMENT Proprietary Device Name: WRENCH Registered Establishment Name: NOBEL BIOCARE USA LLC. |
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Classification: SCREWDRIVER Generic Device Name: PROSTHETIC INSTRUMENT Proprietary Device Name: SCREWDRIVER Registered Establishment Name: NOBEL BIOCARE USA LLC. |
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Classification: EXTRACTOR Generic Device Name: SURGICAL INSTRUMENT Proprietary Device Name: EXTRACTOR Registered Establishment Name: NOBEL BIOCARE USA LLC. |
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Classification: APPARATUS, TRACTION, NON-POWERED Generic Device Name: PORTABLE LUMBAR TRACTION DEVICE Proprietary Device Name: HOMESTRETCH Registered Establishment Name: GLACIER CROSS, INC.. |
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