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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: INSTRUMENT, CAST REMOVAL, AC-POWERED Generic Device Name: TABLET CUTTER Proprietary Device Name: EZY-DOSE TABLET CUTTER Registered Establishment Name: APOTHECARY PRODUCTS, INC.. |
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Classification: PLATE, FIXATION, BONE Generic Device Name: BONE PLATE Proprietary Device Name: AME UNIVERSAL BONE PLATE (UBP) Registered Establishment Name: ORTHOFIX INC.. |
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Classification: IMPLANT, FIXATION DEVICE, SPINAL Generic Device Name: SPINAL FIXATON DEVICE Proprietary Device Name: AME HALIFAX INTERLAMINAR CLAMP Registered Establishment Name: ORTHOFIX INC.. |
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Classification: CERCLAGE, FIXATION Generic Device Name: MULTI-STRAND CABLE Proprietary Device Name: AME SILKON CABLE SYSTEM Registered Establishment Name: ORTHOFIX INC.. |
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Classification: SCREW, FIXATION, BONE Generic Device Name: SCREW,BONE Proprietary Device Name: OGDEN ANCHOR SOFT TISSUE ATTACHMENT DEVICE Registered Establishment Name: ORTHOFIX INC.. |
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Classification: APPLIANCE, FIXATION, SPINAL INTERLAMINAL Generic Device Name: SPINAL INTERLAMINAL FIXATION ORTHOSIS Proprietary Device Name: AME TRIFIX SYSTEM Registered Establishment Name: ORTHOFIX INC.. |
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Classification: PIN, FIXATION, THREADED Generic Device Name: EXTERNAL FIXATION SYSTEM Proprietary Device Name: ORTHOFIX AXIAL FIXATION SYSTEM Registered Establishment Name: ORTHOFIX INC.. |
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Classification: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Generic Device Name: INTERNAL LIMB LENGTHENER Proprietary Device Name: ISKD INTRAMEDULLARY SKELETAL KINETIC DISTRACTOR Registered Establishment Name: ORTHOFIX INC.. |
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Classification: SPLINT, TRACTION Generic Device Name: CID - CERVICAL IMMOBILIZATION DEVICE Proprietary Device Name: SPLINT, TRACTION Registered Establishment Name: S & W ENTERPRISES, INC.. |
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Classification: PIN, FIXATION, SMOOTH Generic Device Name: JURGAN PIN BALLS Proprietary Device Name: JURGAN PIN BALLS Registered Establishment Name: JURGAN DEVELOPMENT & MFG., LTD.. |
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Classification: APPARATUS, TRACTION, NON-POWERED Generic Device Name: TRACTION PATIENT TRANSFER DEVICE Proprietary Device Name: TRANSFER TRAC Registered Establishment Name: COMFORTEX. |
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Classification: BONE MILL Generic Device Name: MANUAL BONE MILL Proprietary Device Name: MINI MILL(TM) Registered Establishment Name: BIOMEDICAL COMPOSITES, LTD.. |
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Classification: APPARATUS, TRACTION, NON-POWERED Generic Device Name: GRAVITY TRACTION/MUSCLE RELAXER Proprietary Device Name: SPINE TRIM Registered Establishment Name: PERFORMANCE ATTAINMENT ASSOC.. |
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Classification: BURR, ORTHOPEDIC Generic Device Name: BURR BRUSH Proprietary Device Name: BURR BRUSH Registered Establishment Name: KEY SURGICAL, INC.. |
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Classification: ARTHROSCOPE Generic Device Name: VARIOUS Proprietary Device Name: ARTHROSCOPE IRRIGATION SYSTEM Registered Establishment Name: DAVOL INC., SUB. C.R. BARD, INC.. |
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Classification: ARTHROSCOPE Generic Device Name: ARTHROSCOPE AND ACCESSORIES Proprietary Device Name: ARTHROSCOPE IRRIGATION SYSTEM Registered Establishment Name: C.R. BARD, INC.. |
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Classification: ARTHROSCOPE Generic Device Name: ARTHROSCOPE AND ACCESSORIES Proprietary Device Name: ARTHROSCOPE IRRIGATION SYSTEM Registered Establishment Name: DAVOL INC., SUB. C.R. BARD, INC.. |
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Classification: NAIL, FIXATION, BONE Generic Device Name: BONE TRIMMER Proprietary Device Name: NAIL TRIMMER Registered Establishment Name: ROBBINS INSTRUMENTS, INC.. |
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Classification: TWISTER, WIRE Generic Device Name: WIRE TWISTER Proprietary Device Name: NONE Registered Establishment Name: ALTO DEVELOPMENT CORP.. |
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Classification: APPARATUS, TRACTION, NON-POWERED Generic Device Name: OVEN DOOR TRACTION Proprietary Device Name: DUNO MOD OVEN DOOR TRACTION Registered Establishment Name: DURO-MED IND., INC.. |
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Classification: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE Generic Device Name: FA TISSUE FIXATIVE AND WASH SET Proprietary Device Name: FA TISSUE FIXATIVE AND WASH SET Registered Establishment Name: ZEUS SCIENTIFIC, INC.. |
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Classification: FIXATION ACCESSORY Generic Device Name: SKULL PIN Proprietary Device Name: RESOLVE CERAMIC TIPPED SKULL PIN Registered Establishment Name: THE JEROME GROUP, INC.. |
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Classification: PROBE Generic Device Name: PROBE, TEMPERATURE Registered Establishment Name: PHYSITEMP INSTRUMENTS, INC.. |
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Classification: PROSTHESIS, INTERVERTEBRAL DISC Generic Device Name: INTERVERTEBRAL DISC PROSTHESIS Proprietary Device Name: S.B. CHARITE Registered Establishment Name: LINK ORTHOPAEDICS. |
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Classification: ARTHROSCOPE Generic Device Name: SPINAL ENDOSCOPIC SYSTEM Proprietary Device Name: VUECATH ENDOSCOPIC SPINAL SYSTEM Registered Establishment Name: ELECTRO-BIOLOGY, INC.. |
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Classification: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY Generic Device Name: SPINAL FIXATION SYSTEM Proprietary Device Name: EBI ANTERIOR CERVICAL SPINE SYSTEM Registered Establishment Name: EBI, L.P.. |
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Classification: PLATE, FIXATION, BONE, NON-SPINAL, METALLIC Generic Device Name: BONE PLATE FIXATION SYSTEM Proprietary Device Name: DYNAFIX VS OSTEOTOMY SYSTEM Registered Establishment Name: EBI, L.P.. |
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Classification: ORTHOSIS, SPINAL PEDICLE FIXATION Generic Device Name: SPINAL FIXATION SYSTEM Proprietary Device Name: OMEGA21 SYSTEM & SPINELINK SYSTEM Registered Establishment Name: EBI, L.P.. |
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Classification: APPLIANCE, FIXATION, SPINAL INTERLAMINAL Generic Device Name: SPINAL FIXATION SYSTEM Proprietary Device Name: OMEGA21 SYSTEM & SPINELINK SYSTEM Registered Establishment Name: EBI, L.P.. |
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Classification: ORTHOSIS, SPONDYLOISTHESIS SPINAL FIXATION Generic Device Name: SPINAL FIXATION SYSTEM Proprietary Device Name: OMEGA21 SYSTEM & SPINELINK SYSTEM Registered Establishment Name: EBI, L.P.. |
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Classification: WRENCH Generic Device Name: VARIOUS Proprietary Device Name: MULTIPLE Registered Establishment Name: EBI, L.P.. |
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Classification: BIT, DRILL Generic Device Name: VARIOUS Proprietary Device Name: MULTIPLE Registered Establishment Name: EBI, L.P.. |
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Classification: TEMPLATE Generic Device Name: VARIOUS Proprietary Device Name: MULTIPLE Registered Establishment Name: EBI, L.P.. |
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Classification: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Generic Device Name: VARIOUS Proprietary Device Name: MULTIPLE Registered Establishment Name: EBI, L.P.. |
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Classification: FILLER, BONE VOID, CALCIUM COMPOUND Generic Device Name: BONE GRAFT SUBSTITUTE Proprietary Device Name: EBI OSTEOSTIM Registered Establishment Name: EBI, L.P.. |
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Classification: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT Generic Device Name: EXTERNAL BONE FIXATOR Proprietary Device Name: EBI XFIX DYNAFIX Registered Establishment Name: EBI, L.P.. |
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Classification: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Generic Device Name: VARIOUS INTRAMEDULLARY FIXATION SYSTEMS Proprietary Device Name: MULTIPLE Registered Establishment Name: EBI, L.P.. |
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Classification: SCREW, FIXATION, BONE Generic Device Name: VARIOUS SCREW FIXATION SYSTEMS Proprietary Device Name: MULTIPLE Registered Establishment Name: EBI, L.P.. |
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Classification: PLATE, FIXATION, BONE Generic Device Name: VARIOUS PLATE FIXATION SYSTEMS Proprietary Device Name: MULTIPLE Registered Establishment Name: EBI, L.P.. |
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Classification: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE Generic Device Name: VARIOUS VERTEBRAL BODY REPLACEMENT DEVICES Proprietary Device Name: MULTIPLE Registered Establishment Name: EBI, L.P.. |
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