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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: GUIDE, DRILL, LIGAMENT Generic Device Name: VARIOUS TYPES OF MARKING HOOKS Proprietary Device Name: ARTHREX MARKING HOOK Registered Establishment Name: ARTHREX, INC.. |
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Classification: REAMER Generic Device Name: VARIOUS SIZES CORING REAMERS AND RELATED ITEMS Proprietary Device Name: ARTHREX CORING REAMER Registered Establishment Name: ARTHREX, INC.. |
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Classification: ARTHROSCOPE Generic Device Name: VARIOUS Proprietary Device Name: MULTIPLE Registered Establishment Name: ARTHREX, INC.. |
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Classification: COMPONENT, TRACTION, NON-INVASIVE Generic Device Name: VARIOUS Proprietary Device Name: MULTIPLE Registered Establishment Name: ARTHREX, INC.. |
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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: ARTHREX, INC.. |
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Classification: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Generic Device Name: VARIOUS Proprietary Device Name: MULTIPLE Registered Establishment Name: ARTHREX, INC.. |
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Classification: SCREW, FIXATION, BONE Generic Device Name: VARIOUS Proprietary Device Name: MULTIPLE Registered Establishment Name: ARTHREX, INC.. |
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Classification: APPARATUS, TRACTION, NON-POWERED Generic Device Name: SHOULDER HOLDER Proprietary Device Name: SHOULDER HOLDER Registered Establishment Name: ARTHREX, INC.. |
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Classification: WASHER, BOLT NUT Generic Device Name: VARIOUS TYPES OF WASHERS Proprietary Device Name: MULTIPLE Registered Establishment Name: ARTHREX, INC.. |
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Classification: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE Generic Device Name: VARIOUS STERILE BIOABSORBABLE SUTURE ANCHORS Proprietary Device Name: MULTIPLE Registered Establishment Name: ARTHREX, INC.. |
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Classification: GAUGE, DEPTH Generic Device Name: VARIUOS DEPTH GAUGES Proprietary Device Name: GAUGE Registered Establishment Name: ARTHREX, INC.. |
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Classification: PROTRACTOR Generic Device Name: PROTRACTOR FOR CLINICAL USE Proprietary Device Name: MEASURING MARLER Registered Establishment Name: ARTHREX, INC.. |
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Classification: CALIPER Generic Device Name: SIZING BLOCK Proprietary Device Name: GRAFT SIZING BLOCK Registered Establishment Name: ARTHREX, INC.. |
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Classification: FILLER, BONE VOID, CALCIUM COMPOUND Generic Device Name: BONE SUBSTITUTE Proprietary Device Name: HATRIC, BONE SUBSTITUTE FOR OPENING WEDGE OSTEOTOMIES Registered Establishment Name: ARTHREX, INC.. |
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Classification: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED Generic Device Name: UNIVERS TOTAL SHOULDER,PROSTHESIS,SEMI-CONTRAINED,METAL/NON-POROUS,CEMENTED VARI Proprietary Device Name: UNIVERS SHOULDER Registered Establishment Name: ARTHREX, INC.. |
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Classification: PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED Generic Device Name: PROSTHESIS,SHOULDER,HEMI-,HUMERAL,METALLIC UNCEMENTED Proprietary Device Name: UNIVERS SHOULDER Registered Establishment Name: ARTHREX, INC.. |
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Classification: APPLIER, CERCLAGE Generic Device Name: APPLIER, CERCLAGE Proprietary Device Name: MULTIPLE Registered Establishment Name: ARTHREX, INC.. |
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Classification: CERCLAGE, FIXATION Generic Device Name: CERCLAGE KIT FOR ORTHOPEDIC USES Proprietary Device Name: ARTHREX CERCLAGE KIT Registered Establishment Name: ARTHREX, INC.. |
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Classification: ACCESSORIES,ARTHROSCOPIC Generic Device Name: OBTURATORS, SHEATHS Proprietary Device Name: ARTHREX INSTRUMENTS Registered Establishment Name: ARTHREX, INC.. |
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Classification: STAPLE, ABSORBABLE Generic Device Name: STAPLE Proprietary Device Name: ARTHREX BIO-TRANSFIX Registered Establishment Name: ARTHREX, INC.. |
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Classification: PIN, FIXATION, SMOOTH Generic Device Name: FIXATION PIN Proprietary Device Name: ARTHREX CHONDRAL DART Registered Establishment Name: ARTHREX, INC.. |
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Classification: INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR AND ACCESSORY/ATTACHMENT Generic Device Name: GRAFT HARVESTING KIT Proprietary Device Name: ARTHREX GRAFT HARVESTING KIT Registered Establishment Name: ARTHREX, INC.. |
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Classification: INSTRUMENT, SURGICAL, ORTHOPEDIC, PNEUMATIC POWERED & ACCESSORY/ATTACHMENT Generic Device Name: HARVESTING SAW Proprietary Device Name: ARTHREX CIRCULAR HARVESTING SAW Registered Establishment Name: ARTHREX, INC.. |
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Classification: BIT, DRILL Generic Device Name: DRILL (VARIOUS SIZE DRILL BITS) Proprietary Device Name: ARTHREX DRILL (VARIOUS SIZE DRILL BITS) Registered Establishment Name: ARTHREX, INC.. |
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Classification: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE Generic Device Name: BONE SCREWS Proprietary Device Name: VARIOUS Registered Establishment Name: ARTHREX, INC.. |
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Classification: PLATE, FIXATION, BONE Generic Device Name: BONE PLATE Proprietary Device Name: ARTHREX OSTEOTOMY PLATES Registered Establishment Name: ARTHREX, INC.. |
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Classification: STAPLE, FIXATION, BONE Generic Device Name: BONE STAPLE Proprietary Device Name: ARTHREX STAPLE Registered Establishment Name: ARTHREX, INC.. |
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Classification: BELT, PELVIC, TRACTION Generic Device Name: BELT, PELVIC, TRACTION Proprietary Device Name: BELT, PELVIC, TRACTION Registered Establishment Name: FLORIDA MFG. CORP.. |
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Classification: COMPONENT, TRACTION, NON-INVASIVE Generic Device Name: COMPONENT, TRACTION, NON-INVASIVE Proprietary Device Name: COMPONENT, TRACTION, NON-INVASIVE Registered Establishment Name: FLORIDA MFG. CORP.. |
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Classification: UNIT, TRACTION, HIP, NON-POWERED, NON-PENETRATING Generic Device Name: UNIT, TRACTION, HIP, NON-POWERED, NON-PENETRATING Proprietary Device Name: UNIT, TRACTION, HIP, NON-POWERED, NON-PENETRATING Registered Establishment Name: FLORIDA MFG. CORP.. |
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Classification: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Generic Device Name: VARIOUS Proprietary Device Name: MULTIPLE Registered Establishment Name: LINVATEC CORP.. |
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Classification: GAUGE, DEPTH Generic Device Name: DRILL GUIDE Proprietary Device Name: ACL/PLC SYSTEM Registered Establishment Name: LINVATEC CORP.. |
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Classification: PASSER, WIRE, ORTHOPEDIC Generic Device Name: GUIDEWIRES,VARIOUS SIZES Proprietary Device Name: HYPERFLEX FLEXIBLE GUIDEWIRE Registered Establishment Name: LINVATEC CORP.. |
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Classification: ARTHROSCOPE Generic Device Name: VARIOUS Proprietary Device Name: MULTIPLE Registered Establishment Name: LINVATEC CORP.. |
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Classification: BIT, DRILL Generic Device Name: DRILL BIT Proprietary Device Name: BADGER DRILL BIT Registered Establishment Name: LINVATEC CORP.. |
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Classification: TAP, BONE Generic Device Name: BONE TAP,VARIOUS SIZES Proprietary Device Name: STANDARD INTERFERENCE SCREW TAP Registered Establishment Name: LINVATEC CORP.. |
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Classification: BURR, ORTHOPEDIC Generic Device Name: BURRS Proprietary Device Name: HALL STERILE BURRS Registered Establishment Name: LINVATEC CORP.. |
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Classification: SYSTEM, CEMENT REMOVAL EXTRACTION Generic Device Name: CEMENT EXTRACTION SYSTEM Proprietary Device Name: HALL SEG-CES SEGMENTAL CEMENT EXTRACTION SYSTEM Registered Establishment Name: LINVATEC CORP.. |
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Classification: WASHER, BOLT NUT Generic Device Name: WASHERS Proprietary Device Name: LINVATEC SPIKED & FLAT WASHERS Registered Establishment Name: LINVATEC CORP.. |
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Classification: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE Generic Device Name: SUTURE ANCHOR Proprietary Device Name: BIO-ANCHOR ABSORBABLE SUTURE ANCHOR Registered Establishment Name: LINVATEC CORP.. |
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