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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: APPARATUS, TRACTION, NON-POWERED Generic Device Name: DISTRACTOR Proprietary Device Name: PORTABLE DISTRACTION SYSTEM Registered Establishment Name: HAYES MEDICAL, INC.. |
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Classification: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS, UNCEMENTED Generic Device Name: PATIENT MATCHED HIP STEM Proprietary Device Name: PATIENT SPECIFIC IMPLANT (PSI) HIP FEMORAL COMPONENT Registered Establishment Name: HAYES MEDICAL, INC.. |
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Classification: IMPACTOR Generic Device Name: VARIOUS Proprietary Device Name: MULTIPLE Registered Establishment Name: HAYES MEDICAL, INC.. |
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Classification: CALIPER Generic Device Name: PATELLA CALIPER Proprietary Device Name: MULTIPLE Registered Establishment Name: HAYES MEDICAL, INC.. |
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Classification: REAMER Generic Device Name: VARIOUS Proprietary Device Name: MULTIPLE Registered Establishment Name: HAYES MEDICAL, INC.. |
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Classification: TEMPLATE Generic Device Name: X-RAY TEMPLATE Proprietary Device Name: MULTIPLE Registered Establishment Name: HAYES MEDICAL, INC.. |
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Classification: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS CEMENTED, OSTEOPHILIC FINISH Generic Device Name: HIP JOINT SYSTEM CONSUSTING OF VARIOUS COMPONENTS COMPONENTS Proprietary Device Name: MULTIPLE Registered Establishment Name: HAYES MEDICAL, INC.. |
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Classification: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED Generic Device Name: HIP JOINT SYSTEM CONSISTING OF VARIOUS COMPONENTS Proprietary Device Name: MULTIPLE Registered Establishment Name: HAYES MEDICAL, INC.. |
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Classification: SCREW, FIXATION, BONE Generic Device Name: BONE SCREW Proprietary Device Name: MULTIPLE Registered Establishment Name: HAYES MEDICAL, INC.. |
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Classification: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER Generic Device Name: KNEE JOINT SYSTEM CONSISTING OF VARIOUS Proprietary Device Name: MULTIPLE Registered Establishment Name: HAYES MEDICAL, INC.. |
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Classification: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED Generic Device Name: HIP JOINT SYSTEM CONSISTING OF VARIOUS COMPONENTS Proprietary Device Name: MULTIPLE Registered Establishment Name: HAYES MEDICAL, INC.. |
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Classification: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER Generic Device Name: KNEE JOINT SYSTEM CONSISTING OF VARIOUS COMPONENTS Proprietary Device Name: MULTIPLE Registered Establishment Name: HAYES MEDICAL, INC.. |
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Classification: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Generic Device Name: INSTRUMENT SET CONSISTING OF VARIOUS SURGICAL INSTRUMENTS Proprietary Device Name: MULTIPLE Registered Establishment Name: HAYES MEDICAL, INC.. |
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Classification: EXTRACTOR Generic Device Name: VARIOUS Proprietary Device Name: MULTIPLE Registered Establishment Name: HAYES MEDICAL, INC.. |
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Classification: BIT, DRILL Generic Device Name: DRILL BIT Proprietary Device Name: MULTIPLE Registered Establishment Name: HAYES MEDICAL, INC.. |
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Classification: BROACH Generic Device Name: FEMORAL BROACH Proprietary Device Name: MULTIPLE Registered Establishment Name: HAYES MEDICAL, INC.. |
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Classification: GAUGE, DEPTH Generic Device Name: DEPTH GAUGE Proprietary Device Name: MULTIPLE Registered Establishment Name: HAYES MEDICAL, INC.. |
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Classification: SCREWDRIVER Generic Device Name: ORTHOPEDIC SCREWDRIVER Proprietary Device Name: UNIVERSAL HEX HEAD SCREWDRIVER Registered Establishment Name: HAYES MEDICAL, INC.. |
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Classification: PROSTHESIS, HIP, FEMORAL, RESURFACING Generic Device Name: HIP JOINT BIPOLAR COMPONENTS, BIPOLAR HEAD AND BIPOLAR INSERT. Proprietary Device Name: MULTIPLE Registered Establishment Name: HAYES MEDICAL, INC.. |
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Classification: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL Generic Device Name: HIP JOINT SYSTEM CONSISTING OF VARIOUS COMPONENTS. Proprietary Device Name: MULTIPLE Registered Establishment Name: HAYES MEDICAL, INC.. |
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Classification: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT Generic Device Name: DERMABRASION Proprietary Device Name: MULTIPLE Registered Establishment Name: MEDICAMAT S.A.. |
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Classification: PROSTHESIS, WRIST, CARPAL TRAPEZIUM Generic Device Name: VARIOUS SIZES OF TRAPEZIO-METACARPAL IMPLANTS Proprietary Device Name: TRAPEZIO-METACARPAL JOINT REPLACEMENT PROSTHESIS Registered Establishment Name: SMALL BONE INNOVATIONS, INC.. |
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Classification: PROSTHESIS, FINGER, POLYMER Generic Device Name: VARIOUS STYLES AND SIZES OF STERILE FINGER JOINT IMPLANTS Proprietary Device Name: NIEBAUER FINGER JOINT REPLACEMTNT PROSTHESIS Registered Establishment Name: SMALL BONE INNOVATIONS, INC.. |
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Classification: PROSTHESIS, TOE, HEMI-, PHALANGEAL Generic Device Name: VARIOUS TYPES AND SIZES OF STERILE IMPLANTS Proprietary Device Name: LESSER TOE PROXIMAL INTERPHALANGEAL JOINT PROSTHESIS Registered Establishment Name: SMALL BONE INNOVATIONS, INC.. |
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Classification: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Generic Device Name: CARPAL TUNNEL RELEASE SYSTEM Proprietary Device Name: GRS CARPAL TUNNEL RELEASE SYSTEM Registered Establishment Name: SMALL BONE INNOVATIONS, INC.. |
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Classification: PLATE, FIXATION, BONE Generic Device Name: DISTAL RADIUS PLATE Proprietary Device Name: SCS/D/ DISTAL RADIUS PLATE Registered Establishment Name: SMALL BONE INNOVATIONS, INC.. |
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Classification: PIN, FIXATION, SMOOTH Generic Device Name: KIRSCHNER WIRE Proprietary Device Name: K-WIRE Registered Establishment Name: SMALL BONE INNOVATIONS, INC.. |
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Classification: PIN, FIXATION, THREADED Generic Device Name: EXTERNAL FIXATOR Proprietary Device Name: EXTERNAL FIXATOR Registered Establishment Name: SMALL BONE INNOVATIONS, INC.. |
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Classification: PROSTHESIS, FINGER, CONSTRAINED, POLYMER Generic Device Name: FINGER JOINT POLYMER CONSTRAINED PROSTHESIS Proprietary Device Name: AVANTA SILICONE MCP, AVANTA SILICONE PRE-FLEX MCP, AVANTA SILICONE PIP Registered Establishment Name: SMALL BONE INNOVATIONS, INC.. |
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Classification: PROSTHESIS, FINGER, CONSTRAINED, METAL/POLYMER Generic Device Name: FINGER JOINT METAL/POLYMER CONSTRAINED CEMENTED PROSTHESIS Proprietary Device Name: AVANTA CMC Registered Establishment Name: SMALL BONE INNOVATIONS, INC.. |
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Classification: PROSTHESIS, WRIST, HEMI-, ULNAR Generic Device Name: VARIOUS STYLES AND SIZES OF STERILE WRIST IMPLANTS Proprietary Device Name: MULTIPLE Registered Establishment Name: SMALL BONE INNOVATIONS, INC.. |
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Classification: PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER Generic Device Name: VARIOUS STYLES AND SIZES OF STERILE ELBOW IMPLANTS Proprietary Device Name: MULTIPLE Registered Establishment Name: SMALL BONE INNOVATIONS, INC.. |
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Classification: PROSTHESIS, TOE, CONSTRAINED, POLYMER Generic Device Name: VARIOUS STYLES AND SIZES OF STERILE TOE IMPLANTS Proprietary Device Name: MULTIPLE Registered Establishment Name: SMALL BONE INNOVATIONS, INC.. |
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Classification: PROSTHESIS, WRIST, 3 PART METAL-PLASTIC-METAL ARTICULATION, SEMI-CONSTRAINED Generic Device Name: WRIST JOINT METAL/POLYMER SEMI-CONSTRAINED CEMENTED PROSTHESIS Proprietary Device Name: AVANTA WRIST Registered Establishment Name: SMALL BONE INNOVATIONS, INC.. |
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Classification: MIXER, CEMENT, FOR CLINICAL USE Generic Device Name: MIXING BOWL Proprietary Device Name: BECHT Registered Establishment Name: ALFRED BECHT GMBH. |
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Classification: BENDER Generic Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Proprietary Device Name: DUNNAMICS Registered Establishment Name: DUNNAMICS, INC.. |
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Classification: ACCESSORIES,ARTHROSCOPIC Generic Device Name: ARTHROSCOPE Proprietary Device Name: DUNNAMICS Registered Establishment Name: DUNNAMICS, INC.. |
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Classification: INSTRUMENT, CAST REMOVAL, AC-POWERED Generic Device Name: CAST REMOVAL INSTRUMENTS Proprietary Device Name: DUNNAMICS Registered Establishment Name: DUNNAMICS, INC.. |
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Classification: INSTRUMENT, CAST APPLICATION/REMOVAL, MANUAL Generic Device Name: MANUAL CAST APPLICATION AND REMOVAL INSTRUMENT Proprietary Device Name: DUNNAMICS Registered Establishment Name: DUNNAMICS, INC.. |
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Classification: SCISSORS, ORTHOPEDIC, SURGICAL Generic Device Name: IRIS Proprietary Device Name: IRIS Registered Establishment Name: MANIKIN TRADERS. |
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