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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: REAMER Generic Device Name: VARIOUS SIZES OF ACETABULAR CUP REAMERS AND ASSOCIATED HANDLES Proprietary Device Name: NONE Registered Establishment Name: ORTHOGENESIS, INC.. |
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Classification: IMPACTOR Generic Device Name: IMPACTOR FOR PLACEMENT OF VARIOUS SIZES OF ACETABULAR CUPS Proprietary Device Name: NONE Registered Establishment Name: ORTHOGENESIS, INC.. |
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Classification: BIT, DRILL Generic Device Name: DRILL BIT Proprietary Device Name: MULTIPLE Registered Establishment Name: ISCON SURGICALS, LTD.. |
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Classification: HOLDER, NEEDLE; ORTHOPEDIC Generic Device Name: NEEDLE HOLDER WITH SCISSORS Proprietary Device Name: OLSEN-HAEGER NEEDLE HOLDER Registered Establishment Name: MEDICAL INSTRUMENT PLANT BY THE NAME OF M. GORKY. |
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Classification: APPARATUS, TRACTION, NON-POWERED Generic Device Name: APPARATUS, TRACTION, NON-POWERED Proprietary Device Name: ARC SURGICAL WRIST TRACTION TOWER Registered Establishment Name: ARC SURGICAL LLC.. |
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Classification: SCREW, FIXATION, BONE Generic Device Name: SMOOTH OR THREADED METALLIC BONE FIXATION FASTENER Proprietary Device Name: ARC SURGICAL RESORBABLE COMPRESSION SCREW SYSTEM Registered Establishment Name: ARC SURGICAL LLC.. |
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Classification: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNCEMENTED Generic Device Name: CERAMIC INSERTS/HEADS, ACETABULAR SHELLS ALTERNATE BEARING Proprietary Device Name: MULTIPLE Registered Establishment Name: ZIMMER LIMITED. |
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Classification: SCISSORS, ORTHOPEDIC, SURGICAL Generic Device Name: SCISSORS Proprietary Device Name: SAILOR SOLDIER SURGICAL CORPORATION Registered Establishment Name: SAILOR SOLDIER SURGICAL CORP.. |
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Classification: DYNAMOMETER, NONPOWERED Generic Device Name: DYNAMOMETER Proprietary Device Name: MULTIPLE Registered Establishment Name: RICHARDSON PRODUCTS, INC.. |
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Classification: INSTRUMENT, COMPRESSION Generic Device Name: VOLUMETER Proprietary Device Name: MULTIPLE Registered Establishment Name: RICHARDSON PRODUCTS, INC.. |
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Classification: GONIOMETER, NONPOWERED Generic Device Name: GONIOMETER Proprietary Device Name: MULTIPLE Registered Establishment Name: RICHARDSON PRODUCTS, INC.. |
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Classification: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Generic Device Name: STERILE AUTOGENOUS BONE CATCHER Proprietary Device Name: AUTOGENOUS BONE CATCHER, (ABC) Registered Establishment Name: SIX-O, LTD.. |
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Classification: APPARATUS, TRACTION, NON-POWERED Generic Device Name: TRACTION TABLE Proprietary Device Name: BACKSOOTHER Registered Establishment Name: PRINCIPAL GROUP LLC, SPORTS EQUIPMENT DIVISION. |
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Classification: GAUGE, DEPTH Generic Device Name: DEPTH GUAGE Proprietary Device Name: DEPTH MEASURING GAUGES Registered Establishment Name: MONDEAL MEDICAL SYSTEMS GMBH. |
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Classification: BIT, DRILL Generic Device Name: DRILL BITS Proprietary Device Name: DRILL BIT (VARIOUS TYPES) Registered Establishment Name: MONDEAL MEDICAL SYSTEMS GMBH. |
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Classification: BENDER Generic Device Name: BENDERS Proprietary Device Name: PLATE BENDING & HOLDING INSTRUMENT (VARIOUS TYPES) Registered Establishment Name: MONDEAL MEDICAL SYSTEMS GMBH. |
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Classification: SCREWDRIVER Generic Device Name: SCREWDRIVERS Proprietary Device Name: SCREWDRIVER (VARIOUS TYPES) Registered Establishment Name: MONDEAL MEDICAL SYSTEMS GMBH. |
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Classification: BRACE, DRILL Generic Device Name: DRILL BRACES Proprietary Device Name: DRILL BRACE (VARIOUS TYPES) Registered Establishment Name: MONDEAL MEDICAL SYSTEMS GMBH. |
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Classification: SCISSORS, ORTHOPEDIC, SURGICAL Generic Device Name: SCISSORS Proprietary Device Name: SCISSORS Registered Establishment Name: BRITISH INSTRUMENTS CO.. |
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Classification: SCISSORS, ORTHOPEDIC, SURGICAL Generic Device Name: SCISSORS Proprietary Device Name: FINE BRO ENTERPRISES Registered Establishment Name: FINE BRO ENTERPRISES. |
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Classification: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Generic Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Proprietary Device Name: MULTIPLE-MANUAL INSTRUMENTS Registered Establishment Name: 3DIMENSIONAL ENGINEERING, INC.. |
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Classification: TAP, BONE Generic Device Name: BONE TAP Proprietary Device Name: SCIENT'X BONE TAPS Registered Establishment Name: 3DIMENSIONAL ENGINEERING, INC.. |
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Classification: KNIFE, ORTHOPEDIC Generic Device Name: KNIFE, ORTHOPEDIC Proprietary Device Name: QAYUM & ELAHISONS Registered Establishment Name: QAYUM & ELAHISONS (PVT), LTD.. |
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Classification: CUTTER, WIRE Generic Device Name: CUTTER, WIRE Proprietary Device Name: QAYUM & ELAHISONS Registered Establishment Name: QAYUM & ELAHISONS (PVT), LTD.. |
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Classification: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Generic Device Name: INSTRUMENT, ORTHOPEDIC, MANUAL SURGICAL Proprietary Device Name: QAYUM & ELAHISONS Registered Establishment Name: QAYUM & ELAHISONS (PVT), LTD.. |
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Classification: SCISSORS, ORTHOPEDIC, SURGICAL Generic Device Name: SCISSORS Proprietary Device Name: QAYUM & ELAHISONS Registered Establishment Name: QAYUM & ELAHISONS (PVT), LTD.. |
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Classification: REAMER Generic Device Name: INTRAMEDULLARY REAMER Proprietary Device Name: FLEX SHAFT REAMER Registered Establishment Name: FLEX TECHNOLOGY INC.. |
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Classification: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, TRUNNION-BEARING Generic Device Name: GLOBAL RESURFACING UNICOMPARTMENTAL KNEE SYSTEM Proprietary Device Name: GLOBAL RESURFACING UNICOMPARTMENTAL KNEE SYSTEM Registered Establishment Name: GLOBAL MANUFACTURING TECHNOLOGY PTY LTD.. |
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Classification: PROSTHESIS, KNEE, HEMI-, TIBIAL, RESURFACING (UNCEMENTED) Generic Device Name: KNEE INTERPOSITIONAL ARTHROPLASTY DEVICE Proprietary Device Name: INTERCUSHION Registered Establishment Name: ADVANCED BIO-SURFACES, INC.. |
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Classification: SCISSORS, ORTHOPEDIC, SURGICAL Generic Device Name: SCISSORS Proprietary Device Name: SCISSORS Registered Establishment Name: ELECTRO PAK DEVICES. |
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Classification: PROBE Generic Device Name: PROBE Proprietary Device Name: PROBE Registered Establishment Name: ELECTRO PAK DEVICES. |
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Classification: REAMER Generic Device Name: VARIOUS TYPES AND SIZES OF REAMERS Proprietary Device Name: MULTIPLE Registered Establishment Name: AMERICAN MEDICALS. |
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Classification: ARTHROSCOPE Generic Device Name: ARTHROSCOPE DEVICES Proprietary Device Name: MULTIPLE Registered Establishment Name: AMERICAN MEDICALS. |
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Classification: ACCESSORIES,ARTHROSCOPIC Generic Device Name: ORTHOPEDIC Proprietary Device Name: MULTIPLE Registered Establishment Name: AMERICAN MEDICALS. |
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Classification: PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER Generic Device Name: PATELLOFEMORAL KNEE Proprietary Device Name: RBK PATELA FEMORAL KNEE SYSTEM Registered Establishment Name: GLOBAL ORTHOPAEDIC TECHNOLOGY, USA, INC.. |
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Classification: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER Generic Device Name: UNICOMPARTMENTAL KNEE REPLACMENT Proprietary Device Name: GLOBAL RESURFACING UNICOMPARTMENTAL KNEE (GRU) SYSTEM Registered Establishment Name: GLOBAL ORTHOPAEDIC TECHNOLOGY, USA, INC.. |
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Classification: ORTHOSIS, SPINAL PEDICLE FIXATION Generic Device Name: ROD AND SCREW SPINAL INSTRUMENTATION Proprietary Device Name: EXCELLA-M SPINAL SYSTEM Registered Establishment Name: INNOVASIS, INC.. |
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Classification: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Generic Device Name: VARIOUS TYPES OF NON-STERILE ORTHOPEDIC MANUAL SURGICAL INSTRUMENTS Proprietary Device Name: MULTIPLE Registered Establishment Name: ALEXANDRIA RESEARCH TECHNOLOGIES, LLC. |
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Classification: FILLER, BONE VOID, CALCIUM COMPOUND Generic Device Name: BONE VOID FILLER SYSTEM(PELLET/KIT) Proprietary Device Name: OSTEO-G Registered Establishment Name: CENTRAL MEDICAL TECHNOLOGIES, INC.. |
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Classification: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT Generic Device Name: VARIOUS SURGICAL BURS Proprietary Device Name: MULTIPLE Registered Establishment Name: MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING. |
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