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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: WASHER, BOLT NUT Generic Device Name: PLASTIC WASHER Proprietary Device Name: PLASTIC WASHER Registered Establishment Name: POLYMED (XIAMEN) PLASTIC INDUSTRIAL CO.,LTD.. |
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Classification: MIXER, CEMENT, FOR CLINICAL USE Generic Device Name: MIXING BOWLS Proprietary Device Name: CARLES MIXING WELLS Registered Establishment Name: AUSTEK, S.R.L.. |
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Classification: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED Generic Device Name: REVISION HIP SYSTEM Proprietary Device Name: PRO-FEMUR R Registered Establishment Name: WRIGHT MEDICAL EUROPE MANUFACTURING SA. |
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Classification: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS CEMENTED, OSTEOPHILIC FINISH Generic Device Name: HIP STEM Proprietary Device Name: PROFEMUR HIP STEM Registered Establishment Name: WRIGHT MEDICAL EUROPE MANUFACTURING SA. |
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Classification: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED Generic Device Name: HIP STEM Proprietary Device Name: PROFEMUR TAPERED HIP STEM Registered Establishment Name: WRIGHT MEDICAL EUROPE MANUFACTURING SA. |
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Classification: PROSTHESIS, HIP, SEMI-CONSTRAINED (METAL UNCEMENTED ACETABULAR COMPONENT) Generic Device Name: ACETABULAR SHELL Proprietary Device Name: PROCOTYL-E ACETABULAR SYSTEM Registered Establishment Name: WRIGHT MEDICAL EUROPE MANUFACTURING SA. |
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Classification: PROSTHESIS, HIP, SEMI-CONSTRAINED (METAL CEMENTED ACETABULAR COMPONENT) Generic Device Name: HIP STEM Proprietary Device Name: PROFEMUR TAPERED HIP STEM Registered Establishment Name: WRIGHT MEDICAL EUROPE MANUFACTURING SA. |
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Classification: BENDER Generic Device Name: BENDER Proprietary Device Name: BENDER Registered Establishment Name: WRIGHT MEDICAL EUROPE MANUFACTURING SA. |
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Classification: BROACH Generic Device Name: BROACH Proprietary Device Name: BROACH Registered Establishment Name: WRIGHT MEDICAL EUROPE MANUFACTURING SA. |
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Classification: IMPACTOR Generic Device Name: IMPACTOR Proprietary Device Name: IMPACTOR Registered Establishment Name: WRIGHT MEDICAL EUROPE MANUFACTURING SA. |
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Classification: BIT, DRILL Generic Device Name: BIT, DRILL Proprietary Device Name: BIT, DRILL Registered Establishment Name: WRIGHT MEDICAL EUROPE MANUFACTURING SA. |
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Classification: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS, UNCEMENTED Generic Device Name: HIP STEM Proprietary Device Name: PROFEMUR HIP STEM Registered Establishment Name: WRIGHT MEDICAL EUROPE MANUFACTURING SA. |
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Classification: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED Generic Device Name: HIP STEM Proprietary Device Name: PROFEMUR R HIP STEM Registered Establishment Name: WRIGHT MEDICAL EUROPE MANUFACTURING SA. |
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Classification: REAMER Generic Device Name: REAMER Proprietary Device Name: REAMER Registered Establishment Name: WRIGHT MEDICAL EUROPE MANUFACTURING SA. |
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Classification: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Generic Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Proprietary Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Registered Establishment Name: WRIGHT MEDICAL EUROPE MANUFACTURING SA. |
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Classification: GAUGE, DEPTH Generic Device Name: GUAGE, DEPTH Proprietary Device Name: GUAGE, DEPTH Registered Establishment Name: WRIGHT MEDICAL EUROPE MANUFACTURING SA. |
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Classification: PROTRACTOR Generic Device Name: P.A.L. PELVIC ALIGNMENT LEVEL Proprietary Device Name: P.A.L. PELVIC ALIGNMENT LEVEL Registered Establishment Name: ORTHOPEDIC SOLUTIONS, INC.. |
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Classification: SCISSORS, ORTHOPEDIC, SURGICAL Generic Device Name: SCISSORS Proprietary Device Name: VARIOUS TYPES OF SCISSORS Registered Establishment Name: M.D. SURGICO. |
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Classification: SCISSORS, ORTHOPEDIC, SURGICAL Generic Device Name: SCISSORS Proprietary Device Name: DODHY BROTHERS Registered Establishment Name: DODHY BROTHERS. |
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Classification: MIXER, CEMENT, FOR CLINICAL USE Generic Device Name: VARIOUS MIXING BOWL Proprietary Device Name: MIXING BOWL Registered Establishment Name: DRILLCO OF AUSTEK S.R.L.. |
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Classification: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED Generic Device Name: TOTAL HIP IMPLANT Proprietary Device Name: MULTIPLE/LATERAL FLARE Registered Establishment Name: STANMORE IMPLANTS WORLDWIDE LTD.. |
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Classification: CALIPER Generic Device Name: SKINFOLD OR BODY FAT TESTER Proprietary Device Name: FATTRACK DIGITAL BODY FAT CALIPER Registered Establishment Name: BERT CORPORATION LTD.. |
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Classification: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED Generic Device Name: TOTAL HIP IMPLANT Proprietary Device Name: MULTIPLE/LATERAL FLARE Registered Establishment Name: PROLFIC LLC.. |
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Classification: BONE CEMENT Generic Device Name: PMMA BONE CEMENT Proprietary Device Name: PALACOS BONE CEMENT Registered Establishment Name: MERCK BIOMATERIAL GMBH. |
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Classification: PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYMER, MOBILE BEARING Generic Device Name: KNEE, PROSTHESIS Proprietary Device Name: OXFORD UNICOMPARTMENTAL KNEE PHASE 3 Registered Establishment Name: BIOMET UK LTD.. |
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Classification: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER Generic Device Name: STERILE FEMORAL COMPONENT OF UNICOMPARTMENTAL PARTIAL KNEE JOINT REPLACEMENT PRO Proprietary Device Name: BIOMET MERCK,OXFORD UNICOMPARTMENTAL KNEE Registered Establishment Name: BIOMET UK LTD.. |
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Classification: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Generic Device Name: VARIOUS TYPES OF MANUAL SURGICAL INSTRUMENTS FOR USE IN ORTHOPEDIC SURGERY Proprietary Device Name: BIOMET MERCK Registered Establishment Name: BIOMET UK LTD.. |
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Classification: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER Generic Device Name: STERILE TOTAL KNEE JOINT REPLACEMENT PROSTHESIS FOR REVISION SURGERY Proprietary Device Name: BIOMET MERCK, AGC REVISION KNEE Registered Establishment Name: BIOMET UK LTD.. |
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Classification: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED Generic Device Name: STERILE TOTAL HIP JOINT REPLACEMENT PROSTHESIS Proprietary Device Name: BIOMET MERCK, STANMORE HIP, SHP HIP Registered Establishment Name: BIOMET UK LTD.. |
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Classification: PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER Generic Device Name: STERILE RADIAL HEAD REPLACEMENT PROSTHESIS Proprietary Device Name: BIOMET MERCK Registered Establishment Name: BIOMET UK LTD.. |
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Classification: PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED Generic Device Name: STERILE RESURFACING SHOULDER JOINT REPLACEMENT PROSTHESIS Proprietary Device Name: BIOMET MERCK, COPELAND SHOULDER Registered Establishment Name: BIOMET UK LTD.. |
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Classification: PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED Generic Device Name: STERILE TOTAL ELBOW JOINT REPLACEMENT PROSTHESIS Proprietary Device Name: BIOMET MERCK, IBP ELBOW Registered Establishment Name: BIOMET UK LTD.. |
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Classification: PLATE, FIXATION, BONE Generic Device Name: EAY, TREND, COMPACT Proprietary Device Name: EAY, TREND, COMPACT Registered Establishment Name: MECCANOTTICA MAZZA. |
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Classification: SCISSORS, ORTHOPEDIC, SURGICAL Generic Device Name: SCISSORS Proprietary Device Name: CARDIAC INSTRUMENTS Registered Establishment Name: CARDIC INSTRUMENTS. |
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Classification: APPARATUS, TRACTION, NON-POWERED Generic Device Name: VTS UNIT Proprietary Device Name: VERTICAL TRACTION SYSTEM UNIT Registered Establishment Name: VERTICAL TRACTION SYSTEM, INC.. |
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Classification: APPARATUS, TRACTION, NON-POWERED Generic Device Name: VTS UNIT Proprietary Device Name: VERTICAL TRACTION SYSTEM UNIT Registered Establishment Name: ENDORPHIN, INC.. |
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Classification: COMPONENT, TRACTION, NON-INVASIVE Generic Device Name: VTS HARNESS Proprietary Device Name: VERTICAL TRACTION SYSTEM HARNESS Registered Establishment Name: VERTICAL TRACTION SYSTEM, INC.. |
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Classification: SCREW, FIXATION, BONE Generic Device Name: COMPRESSION ANCHOR SYSTEM Proprietary Device Name: TITANIUM COMPRESSION ANCHOR SYSTEM Registered Establishment Name: TRIAGE MEDICAL, INC.. |
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Classification: PASSER, WIRE, ORTHOPEDIC Generic Device Name: VARIOUS TYPES OF PASSER WIRES Proprietary Device Name: MULTIPLE Registered Establishment Name: TRIAGE MEDICAL, INC.. |
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Classification: GAUGE, DEPTH Generic Device Name: VARIOUS TYPES OF DEPTH GAGES Proprietary Device Name: MULTIPLE Registered Establishment Name: TRIAGE MEDICAL, INC.. |
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