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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: 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: BIT, DRILL Generic Device Name: VARIOUS TYPES OF SURGICAL, ORTHOPEDIC DRILLS Proprietary Device Name: MULTIPLE Registered Establishment Name: EISENHUT INSTRUMENTE GMBH. |
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Classification: INSTRUMENT, BENDING OR CONTOURING Generic Device Name: INSTRUMENTE, BENDING OR CONTOURING, ORTHOPEDIC Proprietary Device Name: NO PROPRIETARY NAME LISTED Registered Establishment Name: EISENHUT INSTRUMENTE GMBH. |
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Classification: BENDER Generic Device Name: BENDER, ORTHOPEDIC Proprietary Device Name: NO PROPRIETARY NAME LISTED Registered Establishment Name: EISENHUT INSTRUMENTE GMBH. |
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Classification: CUTTER, WIRE Generic Device Name: CUTTER, WIRE, ORTHOPEDIC Proprietary Device Name: NO PROPRIETARY NAME LISTED Registered Establishment Name: EISENHUT INSTRUMENTE GMBH. |
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Classification: CALIPER Generic Device Name: VARIOUS TYPES OF ORTHOPEDIC CALIPERS Proprietary Device Name: MULTIPLE Registered Establishment Name: EISENHUT INSTRUMENTE GMBH. |
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Classification: INSTRUMENT, COMPRESSION Generic Device Name: VARIOUS TYPES OF COMPRESSION INSTRUMENTS Proprietary Device Name: MULTIPLE Registered Establishment Name: EISENHUT INSTRUMENTE GMBH. |
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Classification: PROBE Generic Device Name: ORTHOPEDIC PROBES Proprietary Device Name: PROBES SWITCHING STICKS Registered Establishment Name: ARTHROTEK, INC.. |
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Classification: ARTHROSCOPE Generic Device Name: VARIOUS Proprietary Device Name: MULTIPLE Registered Establishment Name: ARTHROTEK, INC.. |
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Classification: SCREW, FIXATION, BONE Generic Device Name: VARIOUS TYPES OF FIXATION SCREWS Proprietary Device Name: MULTIPLE Registered Establishment Name: ARTHROTEK, INC.. |
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Classification: HALTER, HEAD, TRACTION Generic Device Name: VARIOUS TYPES OF HEAD TRACTION Proprietary Device Name: MULTIPLE Registered Establishment Name: T.S.F. ASSOCIATED CO.. |
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Classification: SPLINT, TRACTION Generic Device Name: HEAD HALTER Proprietary Device Name: MULTIPLE Registered Establishment Name: T.S.F. ASSOCIATED CO.. |
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Classification: SPLINT, TRACTION Generic Device Name: HEAD HALTER Proprietary Device Name: MULTIPLE Registered Establishment Name: DELTAI ENTERPRISE CO. LTD.. |
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Classification: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER Generic Device Name: TOTAL KNEE PROSTHESIS Proprietary Device Name: MTS KNEE SYSTEM CHANGED TO FOUNDATION KNEE SYSTEM Registered Establishment Name: ENCORE MEDICAL, L.P.. |
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Classification: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER Generic Device Name: VARIOUS SIZES OF TOTAL KNEE PROSTHESES, CEMENTED Proprietary Device Name: FOUNDATION KNEE SYSTEM Registered Establishment Name: ENCORE MEDICAL, L.P.. |
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Classification: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Generic Device Name: VARIOUS Proprietary Device Name: MULTIPLE Registered Establishment Name: ENCORE MEDICAL, L.P.. |
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Classification: SCREW, FIXATION, BONE Generic Device Name: VARIOUS Proprietary Device Name: MULTIPLE Registered Establishment Name: ENCORE MEDICAL, L.P.. |
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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: ENCORE MEDICAL, L.P.. |
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Classification: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED Generic Device Name: VARIOUS Proprietary Device Name: MULTIPLE Registered Establishment Name: ENCORE MEDICAL, L.P.. |
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Classification: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED Generic Device Name: VARIOUS Proprietary Device Name: MULTIPLE Registered Establishment Name: ENCORE MEDICAL, L.P.. |
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Classification: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED Generic Device Name: VARIOUS Proprietary Device Name: MULTIPLE Registered Establishment Name: ENCORE MEDICAL, L.P.. |
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Classification: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED Generic Device Name: VARIOUS Proprietary Device Name: MULTIPLE Registered Establishment Name: ENCORE MEDICAL, L.P.. |
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Classification: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Generic Device Name: VARIOUS Proprietary Device Name: MULTIPLE Registered Establishment Name: ENCORE MEDICAL, L.P.. |
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Classification: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS, UNCEMENTED Generic Device Name: VARIOUS Proprietary Device Name: MULTIPLE Registered Establishment Name: ENCORE MEDICAL, L.P.. |
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Classification: CEMENT OBTURATOR Generic Device Name: CEMSTOP Proprietary Device Name: CEMSTOP Registered Establishment Name: ENCORE MEDICAL, L.P.. |
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Classification: BURR, ORTHOPEDIC Generic Device Name: VARIOUS SIZES OF NON-STERILE REAMERS Proprietary Device Name: FOUNDATION KNEE,HIP,SHOULDER INSTRUMENT SYSTEMS/VITALITY HIP INSTRUMENTS SYSTEM Registered Establishment Name: ENCORE MEDICAL, L.P.. |
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Classification: EXTRACTOR Generic Device Name: VARIOUS SIZES OF NONSTERILE IMPLANT EXTRACTOR INSTRUMENTS Proprietary Device Name: FOUNDATION KNEE, HIP & SHOULDER INSTRUMENTATION TRUE/FLEX & TRUE/FIX INSTRUMENAN Registered Establishment Name: ENCORE MEDICAL, L.P.. |
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Classification: DRIVER, PROSTHESIS Generic Device Name: VARIOUS SIZES OF NON-STERILE IMPLANT HOLDERS Proprietary Device Name: FOUNDATION & VITALITY HIP & SHOULDER INSTRUMENTATION; TRUE/FLEX & TRUE/FIT INSTU Registered Establishment Name: ENCORE MEDICAL, L.P.. |
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Classification: BIT, DRILL Generic Device Name: VARIOUS SIZES OF NON-STERILE DRILL BITS Proprietary Device Name: FOUNDATION AND VITALITY HIP,KNEE, AND SHOULDER INSTRUMENT SYSTEMS, TRUE/FIX Registered Establishment Name: ENCORE MEDICAL, L.P.. |
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Classification: PROSTHESIS, HIP, SEMI-CONSTRAINED (METAL UNCEMENTED ACETABULAR COMPONENT) Generic Device Name: VARIOUS SIZES Proprietary Device Name: FOUNDATION METAL/METAL ACETABULAR Registered Establishment Name: ENCORE MEDICAL, L.P.. |
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Classification: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL Generic Device Name: VARIOUS SIZES Proprietary Device Name: FOUNDATION UNIPOLAR Registered Establishment Name: ENCORE MEDICAL, L.P.. |
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Classification: PLATE, FIXATION, BONE, NON-SPINAL, METALLIC Generic Device Name: VARIOUS Proprietary Device Name: TRUE/FIX Registered Establishment Name: ENCORE MEDICAL, L.P.. |
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Classification: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNCEMENTED Generic Device Name: VARIOUS SIZES Proprietary Device Name: FOUNDATION CERAMIC/CERAMIC ACETABULAR SYSTEM Registered Establishment Name: ENCORE MEDICAL, L.P.. |
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Classification: PROSTHESIS, KNEE, JOINT, PATELLOFEMORALTIBIAL, SEMI-CONSTRAINED, CEMENTED, CERAMIC/POLYMER/METAL Generic Device Name: VARIOUS SIZES Proprietary Device Name: CERAMIC FEMUR Registered Establishment Name: ENCORE MEDICAL, L.P.. |
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Classification: WASHER, BOLT, NUT, NON-SPINAL, METALLIC Generic Device Name: VARIOUS Proprietary Device Name: TRUE/FIX, TRUE/LOK Registered Establishment Name: ENCORE MEDICAL, L.P.. |
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Classification: SYSTEM, EXTERNAL FIXATOR (WITH METALLIC INVASIVE COMPONENTS) Generic Device Name: VARIOUS TYPES & SIZES Proprietary Device Name: TRUE/LOK EXTERNAL FIXATOR Registered Establishment Name: ENCORE MEDICAL, L.P.. |
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Classification: SPLINT, TRACTION Generic Device Name: VARIOUS TYPES OF TRACTION SPLINTS Proprietary Device Name: MULTIPLE Registered Establishment Name: ENCORE MEDICAL, L.P.. |
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Classification: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE Generic Device Name: TITANIUM MESH Proprietary Device Name: TITANIUM MESH Registered Establishment Name: ENCORE MEDICAL, L.P.. |
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