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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: SCREWDRIVER Generic Device Name: VARIOUS TYPES OF SCREWDRIVERS Proprietary Device Name: MULTIPLE Registered Establishment Name: SPINEVISION, S.A.. |
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Classification: BENDER Generic Device Name: VARIOUS TYPES OF BENDERS Proprietary Device Name: MULTIPLE Registered Establishment Name: SPINEVISION, S.A.. |
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Classification: APPLIANCE, FIXATION, SPINAL INTERLAMINAL Generic Device Name: SPINAL IMPLANTS AND INSTRUMENTS, KIT AND INDIVIDUAL Proprietary Device Name: MULTIPLE Registered Establishment Name: SPINEVISION, S.A.. |
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Classification: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY Generic Device Name: SPINAL IMPLANTS AND INSTRUMENTS, KIT AND INDIVIDUAL Proprietary Device Name: MULTIPLE Registered Establishment Name: SPINEVISION, S.A.. |
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Classification: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Generic Device Name: VARIOUS TYPES OF ORTHOPEDIC INSTRUMENTS Proprietary Device Name: MULTIPLE Registered Establishment Name: SPINEVISION, S.A.. |
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Classification: ORTHOSIS, SPONDYLOISTHESIS SPINAL FIXATION Generic Device Name: SPINAL IMPLANTS AND INSTRUMENTS, KITS AND INDIVIDUAL Proprietary Device Name: MULTIPLE Registered Establishment Name: SPINEVISION, S.A.. |
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Classification: ORTHOSIS, SPINAL PEDICLE FIXATION Generic Device Name: SPINAL IMPLANTS AND INSTRUMENTS, KIT AND INDIVIDUAL Proprietary Device Name: MULTIPLE Registered Establishment Name: SPINEVISION, S.A.. |
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Classification: REAMER Generic Device Name: VARIOUS TYPES OF REAMERS Proprietary Device Name: MULTIPLE Registered Establishment Name: SPINEVISION, S.A.. |
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Classification: IMPACTOR Generic Device Name: VARIOUS TYPES OF IMPACTORS Proprietary Device Name: MULTIPLE Registered Establishment Name: SPINEVISION, S.A.. |
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Classification: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE Generic Device Name: SPINAL INSTRUMENTATION OR CAGE Proprietary Device Name: MULTIPLE Registered Establishment Name: SPINEVISION, S.A.. |
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Classification: ORTHOSIS, SPINAL INTERVERTEBRAL FUSION Generic Device Name: VARIOUS TYPES OF SPACERS Proprietary Device Name: VIGOR, BULLET, HELIX DISC SPACER Registered Establishment Name: ASPINE USA, INC.. |
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Classification: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE Generic Device Name: VERTBBRAL BODY REPLACEMENT DEVICE Proprietary Device Name: VERTEBRAL BODY SPACER Registered Establishment Name: ASPINE USA, INC.. |
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Classification: ARTHROSCOPE Generic Device Name: ARTHROSCOPY FLUSHING SET Proprietary Device Name: TUTA HEALTHCARE ARTHROSCOPY FLUSHING SET Registered Establishment Name: TUTA HEALTHCARE PTY LIMITED. |
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Classification: PROSTHESIS, WRIST, CONSTRAINED, METAL Generic Device Name: CATHETER/PROBE FIXATION DEVICE Proprietary Device Name: HEMEDEX FIXATION DEVICE Registered Establishment Name: HEMEDEX INCORPORATED. |
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Classification: FIXATION ACCESSORY Generic Device Name: VARIOUS TYPES AND SIZES OF FIXATION ACCESSORIES Proprietary Device Name: MULTIPLE Registered Establishment Name: SYNTHES (USA). |
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Classification: ORTHOSIS, SPONDYLOISTHESIS SPINAL FIXATION Generic Device Name: VARIOUS TYPES AND SIZES OF SPONDYLOLISTHESIS SPINAL FIXATION ORTHOSES Proprietary Device Name: MULTIPLE Registered Establishment Name: SYNTHES (USA). |
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Classification: WIRE, SURGICAL Generic Device Name: VARIOUS TYPES AND SIZES OF SURGICAL WIRES Proprietary Device Name: MULTIPLE Registered Establishment Name: SYNTHES (USA). |
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Classification: PIN, FIXATION, SMOOTH Generic Device Name: VARIOUS TYPES AND SIZES OF SMOOTH FIXATION PINS Proprietary Device Name: MULTIPLE Registered Establishment Name: SYNTHES (USA). |
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Classification: REAMER Generic Device Name: VARIOUS TYPES AND SIZES OF REAMERS Proprietary Device Name: MULTIPLE Registered Establishment Name: SYNTHES (USA). |
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Classification: APPARATUS, TRACTION, NON-POWERED Generic Device Name: VARIOUS TYPES AND SIZES OF NON-POWERED TRACTION COMPONENTS Proprietary Device Name: MULTIPLE Registered Establishment Name: SYNTHES (USA). |
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Classification: PLATE, FIXATION, BONE Generic Device Name: VARIOUS TYPES AND SIZES OF BONE PLATES Proprietary Device Name: MULTIPLE Registered Establishment Name: SYNTHES (USA). |
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Classification: SCREW, FIXATION, BONE Generic Device Name: VARIOUS TYPES AND SIZES OF BONE FIXATION SCREWS Proprietary Device Name: MULTIPLE Registered Establishment Name: SYNTHES (USA). |
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Classification: TAP, BONE Generic Device Name: VARIOUS TYPES AND SIZES OF BONE TAPS Proprietary Device Name: MULTIPLE Registered Establishment Name: SYNTHES (USA). |
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Classification: ORTHOSIS, SPINAL PEDICLE FIXATION Generic Device Name: VARIOUS TYPES AND SIZES OF PEDICLE FIXATION ORTHOSES Proprietary Device Name: MULTIPLE Registered Establishment Name: SYNTHES (USA). |
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Classification: IMPLANT, FIXATION DEVICE, CONDYLAR PLATE Generic Device Name: VARIOUS TYPES AND SIZES OF CONDYLAR PLATE FIXATION DEVICES Proprietary Device Name: MULTIPLE Registered Establishment Name: SYNTHES (USA). |
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Classification: DEVICE, FIXATION, PROXIMAL FEMORAL, IMPLANT Generic Device Name: VARIOUS TYPES AND SIZES OF PROXIMAL FEMUR FIXATION DEVICES Proprietary Device Name: MULTIPLE Registered Establishment Name: SYNTHES (USA). |
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Classification: CERCLAGE, FIXATION Generic Device Name: VARIOUS TYPES AND SIZES OF CERCLAGE WIRES Proprietary Device Name: MULTIPLE Registered Establishment Name: SYNTHES (USA). |
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Classification: PIN, FIXATION, THREADED Generic Device Name: VARIOUS TYPES AND SIZES OF SMOOTH FIXATION PINS Proprietary Device Name: MULTIPLE Registered Establishment Name: SYNTHES (USA). |
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Classification: COMPONENT, TRACTION, INVASIVE Generic Device Name: VARIOUS TYPES AND SIZES OF INVASIVE TRACTION COMPONENTS Proprietary Device Name: MULTIPLE Registered Establishment Name: SYNTHES (USA). |
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Classification: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT Generic Device Name: VARIOUS TYPES AND SIZES OF MULTIPLE COMPONENT FIXATION DEVICES Proprietary Device Name: MULTIPLE Registered Establishment Name: SYNTHES (USA). |
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Classification: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, SINGLE COMPONENT Generic Device Name: VARIOUS TYPES AND SIZES OF SINGLE COMPONENT FIXATION DEVICES Proprietary Device Name: MULTIPLE Registered Establishment Name: SYNTHES (USA). |
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Classification: APPLIANCE, FIXATION, SPINAL INTERLAMINAL Generic Device Name: VARIOUS TYPES AND SIZES OF SPINAL INTERLAMINAL FIXATION DEVICES Proprietary Device Name: MULTIPLE Registered Establishment Name: SYNTHES (USA). |
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Classification: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT, METAL COMPOSITE Generic Device Name: VARIOUS TYPES AND SIZES OF MULTIPLE COMPONENT, METAL COMPOSITE, FIXATION DEVICES Proprietary Device Name: MULTIPLE Registered Establishment Name: SYNTHES (USA). |
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Classification: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY Generic Device Name: ANTERIOR CERVICAL PLATING SYSTEM Proprietary Device Name: ANTERIOR CERVICAL PLATES - ACP Registered Establishment Name: SINTEA BIOTECH SPA. |
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Classification: COMPONENT, TRACTION, INVASIVE Generic Device Name: TRAUMAFIX SYSTEM Proprietary Device Name: SINTEA BIOTECH TRAUMAFIX SYSTEM, MODEL TFX.00.00. Registered Establishment Name: SINTEA BIOTECH SPA. |
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Classification: PIN, FIXATION, THREADED Generic Device Name: SCHANZ SCREW Proprietary Device Name: SINTEA BIOTECH SCHANZ SCREW, MODEL TFX.SS.XX.X Registered Establishment Name: SINTEA BIOTECH SPA. |
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Classification: ORTHOSIS, SPONDYLOISTHESIS SPINAL FIXATION Generic Device Name: POSTERIOR LUMBAR SYSTEM-MULTI-AXIAL Proprietary Device Name: SINTEA BIOTECH POSTERIOR LUMBAR SYSTEM WITH POLYA Registered Establishment Name: SINTEA BIOTECH SPA. |
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Classification: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Generic Device Name: GRAFT TAMP & CANNULAE SYSTEM Proprietary Device Name: LOW PRESSURE SUBSTANCE DELIVERY SYSTEM Registered Establishment Name: YACMUR LLC. |
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Classification: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY Generic Device Name: CERVICAL PLATE Proprietary Device Name: VARIOUS CERVICAL PLATES Registered Establishment Name: RSB SPINE LLC.. |
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Classification: ARTHROSCOPE Generic Device Name: VARIOUS TYPES OF ARTHROSCOPES Proprietary Device Name: ASAP ARTHROSCOPE Registered Establishment Name: ASAP ENDOSCOPIC PRODUCTS GMBH. |
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