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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 TYPES OF REAMERS Proprietary Device Name: MULTIPLE Registered Establishment Name: BIOMET, INC.. |
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Classification: RONGEUR Generic Device Name: VARIOUS TYPES OF ORTHOPEDIC RONGEUR Registered Establishment Name: BIOMET, INC.. |
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Classification: WRENCH Generic Device Name: VARIOUS TYPES OF ORTHOPEDIC WRENCHES Proprietary Device Name: MULTIPLE Registered Establishment Name: BIOMET, INC.. |
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Classification: PASSER, WIRE, ORTHOPEDIC Generic Device Name: VARIOUS ORTHOPEDIC WIRE PASSERS Registered Establishment Name: BIOMET, INC.. |
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Classification: PUSHER, SOCKET Generic Device Name: CUP POSITIONING AND AIMING DEVICE Proprietary Device Name: CUP POSITIONING AND AIMING DEVICE Registered Establishment Name: BIOMET, INC.. |
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Classification: CRIMPER, PIN Generic Device Name: DEE FIXATION CLAMP Proprietary Device Name: DEE FIXATION CLAMP Registered Establishment Name: BIOMET, INC.. |
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Classification: SCREWDRIVER Generic Device Name: VARIOUS TYPES OF ORTHOPEDIC SCREWDRIVERS Proprietary Device Name: MULTIPLE Registered Establishment Name: BIOMET, INC.. |
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Classification: PROSTHESIS, UPPER FEMORAL Generic Device Name: VARIOUS TYPES OF FEMORAL HIP PROSTHESIS Proprietary Device Name: MULTIPLE Registered Establishment Name: BIOMET, INC.. |
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Classification: IMPLANT, FIXATION DEVICE, SPINAL Generic Device Name: MEURIG WILLIAMS PLATE Proprietary Device Name: MEURIG WILLIAMS PLATE Registered Establishment Name: BIOMET, INC.. |
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Classification: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER Generic Device Name: FINN TOTAL KNEE Proprietary Device Name: FINN TOTAL KNEE Registered Establishment Name: BIOMET, INC.. |
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Classification: SYSTEM, CEMENT REMOVAL EXTRACTION Generic Device Name: ULTRASONIC SURGICAL EQUIPMENT Proprietary Device Name: ULTRADRIVE Registered Establishment Name: BIOMET, INC.. |
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Classification: TUBE, CEMENT VENTILATION Generic Device Name: VENT TUBING Proprietary Device Name: VENT TUBING Registered Establishment Name: BIOMET, INC.. |
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Classification: INSTRUMENT, CAST APPLICATION/REMOVAL, MANUAL Generic Device Name: VARIOUS TYPES OF MANUAL CAST REMOVEL INSTRUMENTS. Proprietary Device Name: MULTIPLE Registered Establishment Name: BIOMET, INC.. |
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Classification: PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED Generic Device Name: VARIOUS TYPES OF STERILE AND NON-STERILE TOTAL ELBOWS. Proprietary Device Name: MULTIPLE Registered Establishment Name: BIOMET, INC.. |
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Classification: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED Generic Device Name: VARIOUS TYPES OF HIP[ PROSTHESES Proprietary Device Name: MULTIPLE Registered Establishment Name: BIOMET, INC.. |
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Classification: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS, UNCEMENTED Generic Device Name: VARIOUS TYPES OF HIP PROSTHESIS AND CERAMIC HEAD. Proprietary Device Name: MULTIPLE Registered Establishment Name: BIOMET, INC.. |
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Classification: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED Generic Device Name: VARIOUS TYPES OF HIP, MODULAR HEADS, ANDACETABULAR PROSTHESIS Proprietary Device Name: MULTIPLE Registered Establishment Name: BIOMET, INC.. |
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Classification: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICUM-PHOSPHATE Generic Device Name: BIO-GROOVE HA Proprietary Device Name: BIO-GROOVE HA Registered Establishment Name: BIOMET, INC.. |
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Classification: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER Generic Device Name: VARIOUS TYPES OF KNEE PROSTHESIS Proprietary Device Name: MULTIPLE Registered Establishment Name: BIOMET, INC.. |
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Classification: PROSTHESIS, TOE (METATARSOPHALANGEAL), JOINT, METAL/POLYMER, SEMI-CONSTRAINED Generic Device Name: TOTAL TOE Proprietary Device Name: TOTAL TOE Registered Establishment Name: BIOMET, INC.. |
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Classification: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED Generic Device Name: BIO-MODULAR SHOULDER, BI-ANGULAR SHOULDER Proprietary Device Name: BIO-MODULAR SHOULDER, BI-ANGULAR SHOULDER Registered Establishment Name: BIOMET, INC.. |
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Classification: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL Generic Device Name: VARIOUS TYPES OF FEMORAL TOTAL HIP PROSTHESIS Proprietary Device Name: MULTIPLE Registered Establishment Name: BIOMET, INC.. |
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Classification: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER Generic Device Name: VARIOUS TYPES OF KNEE PROSTHESIS Proprietary Device Name: MULTIPLE Registered Establishment Name: BIOMET, INC.. |
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Classification: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT Generic Device Name: VARIOUS TYEPS OF ELECTRICAL POWERED SURGICAL INSTRUMENTS Proprietary Device Name: MULTIPLE Registered Establishment Name: BIOMET, INC.. |
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Classification: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE Generic Device Name: HARPOON SUTURE ANCHOR Proprietary Device Name: HARPOON SUTURE ANCHOR Registered Establishment Name: BIOMET, INC.. |
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Classification: PIN, FIXATION, SMOOTH Generic Device Name: FIXATION PIN OR ROD Proprietary Device Name: LACTO BONE PIN Registered Establishment Name: BIOMET, INC.. |
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Classification: BONE CEMENT Generic Device Name: PMMA BONE CEMENT Proprietary Device Name: PALACOS GENERATION 4 Registered Establishment Name: BIOMET, INC.. |
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Classification: PROBE Generic Device Name: VARIOUS Proprietary Device Name: MULTIPLE Registered Establishment Name: BIOMET, INC.. |
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Classification: STAPLE, FIXATION, BONE Generic Device Name: MENISCAL STAPLE Proprietary Device Name: LACTOSORB MENISCAL REPAIR DEVICE Registered Establishment Name: BIOMET, INC.. |
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Classification: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE Generic Device Name: VARIOUS TYPES OF LACTOSORB STERILE & NON-STERILE Proprietary Device Name: MULTIPLE Registered Establishment Name: BIOMET, INC.. |
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Classification: PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED Generic Device Name: VARIOUS TYPES OF STERILE & NON-STERILE ELBOW COMPONENTS Proprietary Device Name: MULTIPLE Registered Establishment Name: BIOMET, INC.. |
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Classification: PROSTHESIS, HIP, SEMI-CONSTRAINED (METAL UNCEMENTED ACETABULAR COMPONENT) Generic Device Name: VARIOUS TYPES OF HIP PROSTHESIS FOR STERILE & NON-STERILE Proprietary Device Name: MULTIPLE Registered Establishment Name: BIOMET, INC.. |
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Classification: PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED Generic Device Name: VARIOUS TYPES OF STERILE & NON-STERILE SHOULDER COMPONENTS Proprietary Device Name: MULTIPLE Registered Establishment Name: BIOMET, INC.. |
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Classification: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Generic Device Name: VARIOUS INSTRUMENTS, CEMENT GUN INSERTER APPLICATORS, TEMPLATES, GAGE SETS Proprietary Device Name: ORTHOPEDIC INSTRUMENT SET, PROVISIONAL TRIAL PROSTHESIS, CEMENTING EQUIPMENT Registered Establishment Name: BIOMET, INC.. |
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Classification: PROSTHESIS, HIP, FEMORAL, RESURFACING Generic Device Name: VARIOUS RESURFACING FEMORAL HIP COMPONENTS Proprietary Device Name: MULTIPLE Registered Establishment Name: BIOMET, INC.. |
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Classification: BROACH Generic Device Name: VARIOUS TYPES OF BROACHS Proprietary Device Name: MULTIPLE Registered Establishment Name: BIOMET, INC.. |
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Classification: PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED Generic Device Name: VARIOUS TYPES OF STERILE AND NON-STERILE SHOULDER PROSTHESIS Proprietary Device Name: MULTIPLE Registered Establishment Name: BIOMET, INC.. |
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Classification: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED Generic Device Name: VARIOUS TYPES OF STERILE AND NON-STERILE SHOULDER PROSTHESIS Proprietary Device Name: MULTIPLE Registered Establishment Name: BIOMET, INC.. |
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Classification: BIT, DRILL Generic Device Name: VARIOUS TYPES OF DRILL BITS Proprietary Device Name: MULTIPLE Registered Establishment Name: BIOMET, INC.. |
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Classification: PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER Generic Device Name: VARIOUS TYPES OF HIP PROSTHESIS Proprietary Device Name: FREEDOM CONSTRAINED LINER Registered Establishment Name: BIOMET, INC.. |
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