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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: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL Generic Device Name: VARIOUS TYPES OF HIP PROSTHESES Proprietary Device Name: MULTIPLE Registered Establishment Name: SMITH & NEPHEW ORTHOPAEDICS, GMBH. |
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Classification: PROSTHESIS, UPPER FEMORAL Generic Device Name: VARIOUS TYPES OF FEMORAL PROSTHESES Proprietary Device Name: MULTIPLE Registered Establishment Name: SMITH & NEPHEW ORTHOPAEDICS, GMBH. |
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Classification: SCREW, FIXATION, BONE Generic Device Name: VARIOUS TYPES OF BONE FIXATION SCREWS Proprietary Device Name: MULTIPLE Registered Establishment Name: SMITH & NEPHEW ORTHOPAEDICS, GMBH. |
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Classification: COMPONENT, TRACTION, INVASIVE Generic Device Name: VARIOUS TYPES OF INVASIVE TRACTION COMPONENTS Proprietary Device Name: MULTIPLE Registered Establishment Name: SMITH & NEPHEW ORTHOPAEDICS, GMBH. |
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Classification: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER Generic Device Name: VARIOUS TYPES OF KNEE PROSTHESES Proprietary Device Name: MULTIPLE Registered Establishment Name: SMITH & NEPHEW ORTHOPAEDICS, GMBH. |
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Classification: PLATE, FIXATION, BONE Generic Device Name: VARIOUS TYPES OF BONE FIXATION PLATES Proprietary Device Name: MULTIPLE Registered Establishment Name: SMITH & NEPHEW ORTHOPAEDICS, GMBH. |
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Classification: PIN, FIXATION, THREADED Generic Device Name: VARIOUS TYPES OF THREADED FIXATION PINS Proprietary Device Name: MULTIPLE Registered Establishment Name: SMITH & NEPHEW ORTHOPAEDICS, GMBH. |
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Classification: PIN, FIXATION, SMOOTH Generic Device Name: VARIOUS TYPES OF SMOOTH FIXATION PINS Proprietary Device Name: MULTIPLE Registered Establishment Name: SMITH & NEPHEW ORTHOPAEDICS, GMBH. |
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Classification: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT Generic Device Name: VARIOUS TYPES OF FIXATION APPLIANCES Proprietary Device Name: MULTIPLE Registered Establishment Name: SMITH & NEPHEW ORTHOPAEDICS, GMBH. |
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Classification: STAPLE, FIXATION, BONE Generic Device Name: BONE FIXATION STAPLE Proprietary Device Name: FIXATION STAPLE Registered Establishment Name: SMITH & NEPHEW ORTHOPAEDICS, GMBH. |
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Classification: CERCLAGE, FIXATION Generic Device Name: BONE FIXATION CERCLAGE Proprietary Device Name: FIXATION CERCLAGE Registered Establishment Name: SMITH & NEPHEW ORTHOPAEDICS, GMBH. |
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Classification: NAIL, FIXATION, BONE Generic Device Name: INTRAMEDULLARY NAIL Proprietary Device Name: INTRAMEDULLARY NAIL Registered Establishment Name: SMITH & NEPHEW ORTHOPAEDICS, GMBH. |
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Classification: PLATE, FIXATION, BONE Generic Device Name: VARIOUS TYPES AND SIZES OF BONE FIXATION PLATES Registered Establishment Name: GYRUS ENT L.L.C.. |
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Classification: SCREW, FIXATION, BONE Generic Device Name: VARIOUS TYPES AND SIZES OF BONE FIXATION SCREWS Registered Establishment Name: GYRUS ENT L.L.C.. |
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Classification: CERAMICS, CALCIUM TRIPHOSPHATE/HYDROXYPATITE, NON-LOAD BEARING USES Generic Device Name: VARIOUS TYPES AND SIZES OF HYDROXYPATITE BLOCKS Registered Establishment Name: GYRUS ENT L.L.C.. |
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Classification: DYNAMOMETER, NONPOWERED Generic Device Name: GRIP METER Proprietary Device Name: DIGITAL GRIP Registered Establishment Name: CHATTANOOGA GROUP. |
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Classification: GONIOMETER, NONPOWERED Generic Device Name: VARIOUS MODELS OF LMM (LUMBAR MOTION MONITOR) Registered Establishment Name: CHATTANOOGA GROUP. |
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Classification: APPARATUS, TRACTION, NON-POWERED Generic Device Name: TRACTION UNIT FOR HOME USE Proprietary Device Name: OVER THE DOOR TRACTION UNIT Registered Establishment Name: CHATTANOOGA GROUP. |
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Classification: COMPONENT, TRACTION, NON-INVASIVE Generic Device Name: TRACTION KIT Proprietary Device Name: SHOULDER TRACTION KIT Registered Establishment Name: CHATTANOOGA GROUP. |
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Classification: CALIPER Generic Device Name: CALIPER Proprietary Device Name: BASELINE CALIPERS Registered Establishment Name: CHATTANOOGA GROUP. |
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Classification: BELT, PELVIC, TRACTION Generic Device Name: PELVIC TRACTION BELT Proprietary Device Name: PELVIC TRACTION BELT Registered Establishment Name: PROFESSIONAL PRODUCTS, INC.. |
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Classification: IMPLANT, FIXATION DEVICE, SPINAL Generic Device Name: CROSSLINE SYSTEM Registered Establishment Name: MEDTRONIC SOFAMOR DANEK USA, INC.. |
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Classification: TAP, BONE Generic Device Name: TAP, BONE SCREW Registered Establishment Name: MEDTRONIC SOFAMOR DANEK USA, INC.. |
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Classification: ACCESSORIES, FIXATION, SPINAL INTERLAMINAL Generic Device Name: SPINAL IMPLANT FIXATION DEVICE Proprietary Device Name: TSRH CROSSLINK SYSTEM Registered Establishment Name: MEDTRONIC SOFAMOR DANEK USA, INC.. |
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Classification: ACCESSORIES, FIXATION, SPINAL INTERVERTEBRAL BODY Generic Device Name: SPINAL IMPLANT FIXATION DEVICES Proprietary Device Name: TACOMA PLATING SYSTEM,RAY SACRAL PLATING SYSTEM Registered Establishment Name: MEDTRONIC SOFAMOR DANEK USA, INC.. |
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Classification: CERCLAGE, FIXATION Generic Device Name: CABLE DEVICE - STERILE AND NON-STERILE Proprietary Device Name: MULTIPLE Registered Establishment Name: MEDTRONIC SOFAMOR DANEK USA, INC.. |
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Classification: ORTHOSIS, FIXATION, SPINAL CERVICAL INTERVERTEBRAL BODY Generic Device Name: CERVICAL IMPLANT FIXATION DEVICE Proprietary Device Name: ORION ANTERIOR CERVICAL PLATE SYSTEM Registered Establishment Name: MEDTRONIC SOFAMOR DANEK USA, INC.. |
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Classification: PLATE, FIXATION, BONE Generic Device Name: BONE PLATE DEVICES Proprietary Device Name: MULTIPLE Registered Establishment Name: MEDTRONIC SOFAMOR DANEK USA, INC.. |
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Classification: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY Generic Device Name: ANTERIOR FIXATION DEVICES Proprietary Device Name: MULTIPLE, TSRH, CD HORIZON, DYNALOK, ATLANTIS, ZPLATE-ATL, PYRAMID, VERTE-STACK Registered Establishment Name: MEDTRONIC SOFAMOR DANEK USA, INC.. |
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Classification: ARTHROSCOPE Generic Device Name: ARTHROSCOPIC SYSTEM Proprietary Device Name: MULTIPLE Registered Establishment Name: MEDTRONIC SOFAMOR DANEK USA, INC.. |
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Classification: SYSTEM, FACET SCREW SPINAL DEVICE Generic Device Name: VARIOUS Proprietary Device Name: MULTIPLE Registered Establishment Name: MEDTRONIC SOFAMOR DANEK USA, INC.. |
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Classification: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT Generic Device Name: VARIOUS SURGICAL BURS Proprietary Device Name: MULTIPLE Registered Establishment Name: MEDTRONIC SOFAMOR DANEK USA, INC.. |
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Classification: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Generic Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Proprietary Device Name: MULTIPLE Registered Establishment Name: MEDTRONIC SOFAMOR DANEK USA, INC.. |
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Classification: CRIMPER, PIN Generic Device Name: VARIOUS TENSION CRIMPER Proprietary Device Name: MULTIPLE Registered Establishment Name: MEDTRONIC SOFAMOR DANEK USA, INC.. |
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Classification: REAMER Generic Device Name: MULTIPLE (ORTHOPEDIC REAMERS) Proprietary Device Name: MULTIPLE (ORTHOPEDIC REAMERS) Registered Establishment Name: MEDTRONIC SOFAMOR DANEK USA, INC.. |
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Classification: BIT, DRILL Generic Device Name: VARIOUS TWIST, BIT DRILLS Proprietary Device Name: MULTIPLE TWIST, BIT DRILLS Registered Establishment Name: MEDTRONIC SOFAMOR DANEK USA, INC.. |
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Classification: ORTHOSIS, SPINAL PEDICLE FIXATION Generic Device Name: VARIOUS SPINAL IMPLANT FIXATION DEVICES Proprietary Device Name: MULTIPLE Registered Establishment Name: MEDTRONIC SOFAMOR DANEK USA, INC.. |
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Classification: PLATE, FIXATION, BONE, NON-SPINAL, METALLIC Generic Device Name: AXIS, TIMESH, ATLAS Proprietary Device Name: AXIS, TIMESH, ATLAS Registered Establishment Name: MEDTRONIC SOFAMOR DANEK USA, INC.. |
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Classification: SCREW, FIXATION, BONE, NON-SPINAL, METALLIC Generic Device Name: UCSS, ATLAS Proprietary Device Name: UCSS, ATLAS Registered Establishment Name: MEDTRONIC SOFAMOR DANEK USA, INC.. |
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Classification: WIRE, SURGICAL Generic Device Name: SURGICAL CABLE Proprietary Device Name: ATLAS Registered Establishment Name: MEDTRONIC SOFAMOR DANEK USA, INC.. |
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