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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: ACCESSORIES,ARTHROSCOPIC Generic Device Name: VARIOUS TYPES OF CANNULAS Proprietary Device Name: CANNULA Registered Establishment Name: SPINE WAVE, INC.. |
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Classification: PLATE, FIXATION, BONE Generic Device Name: WAFER SYSTEM Proprietary Device Name: STAXX WAFER SYSTEM Registered Establishment Name: SPINE WAVE, INC.. |
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Classification: EXTRACTOR Generic Device Name: PIN PULLER Proprietary Device Name: PIN PULLER Registered Establishment Name: SPINE WAVE, INC.. |
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Classification: IMPACTOR Generic Device Name: MALLET Proprietary Device Name: MALLET Registered Establishment Name: SPINE WAVE, INC.. |
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Classification: HOLDER, NEEDLE; ORTHOPEDIC Generic Device Name: NEEDLE HOLDERS Proprietary Device Name: MULTIPLE Registered Establishment Name: MIBE CORP.. |
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Classification: CERCLAGE, FIXATION Generic Device Name: INTERNAL FRACTURE FIXATION DEVICE Proprietary Device Name: OSSE-LIGN Registered Establishment Name: OSSEUS, LLC. |
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Classification: APPARATUS, TRACTION, NON-POWERED Generic Device Name: KNEE EXTENSION DEVICE Proprietary Device Name: 3X10=0 Registered Establishment Name: IHN, INC.. |
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Classification: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE Generic Device Name: SUSTAIN SPACER Proprietary Device Name: SUSTAIN SPACER Registered Establishment Name: GLOBUS MEDICAL, INC.. |
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Classification: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY Generic Device Name: ANTERIOR CERVICAL PLATE SYSTEM Proprietary Device Name: ASSURE ANTERIOR CERVICAL PLATE SYSTEM Registered Establishment Name: GLOBUS MEDICAL, INC.. |
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Classification: ORTHOSIS, SPINAL PEDICLE FIXATION Generic Device Name: SPINAL INTERLAMINAL & INTERVERTEBAL BODY FIXATION ORTHOSIS & PED Proprietary Device Name: PROTEX STABILIZATION SYSTEM Registered Establishment Name: GLOBUS MEDICAL, INC.. |
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Classification: SCISSORS, ORTHOPEDIC, SURGICAL Generic Device Name: SCISSORS Proprietary Device Name: STYREX TRADERS Registered Establishment Name: STYREX TRADERS. |
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Classification: INSTRUMENT, CAST REMOVAL, AC-POWERED Generic Device Name: VARIOUS TYPE OF CASTING MACHINE Proprietary Device Name: MULTIPLE (INSTRUMENT, CAST REMOVAL, AC-POWERED) Registered Establishment Name: SHOFU INC.. |
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Classification: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED Generic Device Name: TOTAL HIP SYSTEM Proprietary Device Name: C TOTAL HIP SYSTEM Registered Establishment Name: ORTHOPEDIC ALLIANCE LLC. |
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Classification: ORTHOSIS, SPINAL PEDICLE FIXATION Generic Device Name: PEDICLE SCREW SPINAL SYSTEM Proprietary Device Name: ORTHOPEDIC ALLIANCE SPINE SYSTEM Registered Establishment Name: ORTHOPEDIC ALLIANCE LLC. |
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Classification: BELT, PELVIC, TRACTION Generic Device Name: VARIOUS TYPES OF BELTS FOR PELVIC TRACTION Proprietary Device Name: TEXAS ORTHOPAEDIC PRODUCTS & SERVICES, L.L.C. Registered Establishment Name: TEXAS ORTHOPAEDIC PRODUCTS & SERVICES, L.L.C.. |
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Classification: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Generic Device Name: INTERVERTEBRAL SPACER DISTRACTION SYSTEM Proprietary Device Name: MULTIPLE Registered Establishment Name: SUMMIT CORPORATE SERVICES, INC.. |
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Classification: COMPONENT, CAST Generic Device Name: CAST COMPONENT Proprietary Device Name: MULTIPLE Registered Establishment Name: SOUND MEDICAL CORP.. |
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Classification: SCISSORS, ORTHOPEDIC, SURGICAL Generic Device Name: SCISSORS Proprietary Device Name: FAIBA INTERNATIONAL Registered Establishment Name: FAIBA INTERNATIONAL. |
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Classification: PROBE Generic Device Name: PROBE Proprietary Device Name: PROBE Registered Establishment Name: CLINIMED INSTRUMENTE GMBH. |
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Classification: HOLDER, NEEDLE; ORTHOPEDIC Generic Device Name: NEEDLE HOLDER Proprietary Device Name: HOLDER,NEEDLE;ORTHOPEDIC Registered Establishment Name: CLINIMED INSTRUMENTE GMBH. |
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Classification: CUTTER, WIRE Generic Device Name: WIRE CUTTER Proprietary Device Name: CUTTER,WIRE Registered Establishment Name: CLINIMED INSTRUMENTE GMBH. |
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Classification: BIT, DRILL Generic Device Name: KIRSHNER WIRE DRILL Proprietary Device Name: KIRSHNER WIRE DRILL Registered Establishment Name: CLINIMED INSTRUMENTE GMBH. |
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Classification: PROSTHESIS, KNEE, HEMI-, FEMORAL Generic Device Name: MEDICAL DEVICES - IMPLANTS - VARIOUS TYPES Proprietary Device Name: MEDICAL DEVICES - IMPLANTS - VARIOUS TYPES Registered Establishment Name: USAEROTEAM. |
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Classification: PLATE, FIXATION, BONE Generic Device Name: CERVICAL LAMINOPLASTY PLATES Proprietary Device Name: CG SURGICAL OPEN-DOOR CERVICAL LAMINOPLASTY PLATES Registered Establishment Name: CG SURGICAL LTD.. |
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Classification: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT Generic Device Name: DISTRACTION DEVICE FEMUR Proprietary Device Name: INTER-OS LIMB LENGTHENER Registered Establishment Name: ORTHONETX, INC.. |
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Classification: ORTHOSIS, SPINAL PEDICLE FIXATION Generic Device Name: PEDICLE SCREW SYSTEM Proprietary Device Name: PSS PEDICLE SCREW SYSTEM Registered Establishment Name: VERTEBRON, INC.. |
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Classification: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY Generic Device Name: CERVICAL PLATE Proprietary Device Name: SCP CERVICAL PLATE Registered Establishment Name: VERTEBRON, INC.. |
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Classification: ORTHOSIS, SPINAL PEDICLE FIXATION Generic Device Name: PEDICLE SCREW SYSTEM Proprietary Device Name: ART PEDICLE SCREW SYSTEM Registered Establishment Name: ADVANCED MEDICAL TECHNOLOGIES AG. |
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Classification: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY Generic Device Name: ANTERIOR SPINAL PLATE Proprietary Device Name: AMT ANTERIOR THORACULUMBAR PLATE SYSTEM Registered Establishment Name: ADVANCED MEDICAL TECHNOLOGIES AG. |
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Classification: SCISSORS, ORTHOPEDIC, SURGICAL Generic Device Name: SCISSORS Proprietary Device Name: MULTIPLE Registered Establishment Name: CHINALIGHT TRI-UNION INTERNATIONAL CO., LTD.. |
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Classification: PROBE Generic Device Name: VARIOUS PROBES Proprietary Device Name: MULTIPLE Registered Establishment Name: SURVICO INDUSTRIES, INC.. |
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Classification: SCISSORS, ORTHOPEDIC, SURGICAL Generic Device Name: VARIOUS Proprietary Device Name: MULTIPLE Registered Establishment Name: SURVICO INDUSTRIES, INC.. |
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Classification: BELT, PELVIC, TRACTION Generic Device Name: PELVIC TRACTION, BELT Proprietary Device Name: PREMIUM, UNIVERSAL Registered Establishment Name: JIUNDAR INDUSTRIAL CO., LTD.. |
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Classification: PROSTHESIS, WRIST, CARPAL TRAPEZIUM Generic Device Name: SPACER Proprietary Device Name: ARTELON SPACER CMC-I #21109 Registered Establishment Name: ARTIMPLANT AB. |
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Classification: INSTRUMENT, SURGICAL, ORTHOPEDIC, PNEUMATIC POWERED & ACCESSORY/ATTACHMENT Generic Device Name: POWERED ORTHOPEDIC SURGICAL INSTRUMENT Proprietary Device Name: EMS SWISS ORTHOCLAST Registered Establishment Name: E.M.S. ELECTRO MEDICAL SYSTEMS S.A.. |
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Classification: TEMPLATE Generic Device Name: HIP GAUGE, FEMOROACETABULUM GAUGE, CUSTOMIZED FOR HIP PRESERVATION SURGERY Proprietary Device Name: FAI GAUGE Registered Establishment Name: MASSCUS TECHNOLOGIES. |
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Classification: SCREW, FIXATION, BONE Generic Device Name: FLAT FOOT IMPLANT Proprietary Device Name: KALIX Registered Establishment Name: DEDIENNE SANTE SME CORPORATION. |
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Classification: STAPLE, FIXATION, BONE Generic Device Name: BONE FIXATION STAPLE Proprietary Device Name: UNI-CLIP Registered Establishment Name: E.C. MAYET. |
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Classification: SCISSORS, ORTHOPEDIC, SURGICAL Generic Device Name: SCISSORS Proprietary Device Name: SABRI INDUSTRIES Registered Establishment Name: SABRI INDUSTRIES. |
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Classification: RONGEUR Generic Device Name: RONGEURS Proprietary Device Name: SABRI INDUSTRIES Registered Establishment Name: SABRI INDUSTRIES. |
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