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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: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY Generic Device Name: ANTERIOR SPINE BONE PLATE Proprietary Device Name: CASF (CONTOURED ANTERIOR SPINAL FIXATION) SYSYEM Registered Establishment Name: DEPUY SPINE, INC.. |
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Classification: PROSTHESIS, INTERVERTEBRAL DISC Generic Device Name: INTERVERTEBRAL DISC PROSTHESIS WITH RELATED INSTRUMENTATION Proprietary Device Name: CHARITE ARTIFICIAL DISC Registered Establishment Name: DEPUY SPINE, INC.. |
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Classification: COMPONENT, CAST Generic Device Name: VARIOUS VACUUM BAG AND LOW MELT PLASTIC CAST SUPPORTS Proprietary Device Name: MULTIPLE Registered Establishment Name: BIONIX DEVELOPMENT CORP.. |
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Classification: INSTRUMENT, CAST REMOVAL, AC-POWERED Generic Device Name: POWERED CAST SAW Proprietary Device Name: NO PROPRIETARY NAME LISTED Registered Establishment Name: DEBUSK ORTHOPEDIC CASTING (DOC). |
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Classification: COMPONENT, CAST Generic Device Name: VARIOUS TYPES OF PLASTERS Proprietary Device Name: MULTIPLE Registered Establishment Name: DEBUSK ORTHOPEDIC CASTING (DOC). |
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Classification: BELT, PELVIC, TRACTION Generic Device Name: VARIOUS, SIZES, STYLES & DESIGNS Proprietary Device Name: BAYLOR PELVIC TRACTION BELT Registered Establishment Name: TEXAS MEDICAL INDUSTRIES, INC.. |
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Classification: APPARATUS, TRACTION, NON-POWERED Generic Device Name: VARIOUS SIZES OF TRACTION WEIGHTS; TRACTION CARTS Proprietary Device Name: CAST IRON WEIGHTS & HANGERS; TMI CART Registered Establishment Name: TEXAS MEDICAL INDUSTRIES, INC.. |
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Classification: SPLINT, TRACTION Generic Device Name: BUCK'S TRACTION DEVICE Proprietary Device Name: BUCK'S TRACTION DEVICE Registered Establishment Name: TEXAS MEDICAL INDUSTRIES, INC.. |
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Classification: INSTRUMENT, SURGICAL, ORTHOPEDIC, PNEUMATIC POWERED & ACCESSORY/ATTACHMENT Generic Device Name: VARIOUS MODELS OF MOTORS/ATTACH.VARIOUS STERILE/NON-STERILE ACCESSORIES Proprietary Device Name: BONE SCALPEL ACRYLO-OSTEOTOME Registered Establishment Name: MEDTRONIC POWERED SURGICAL SOLUTIONS. |
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Classification: INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR AND ACCESSORY/ATTACHMENT Generic Device Name: ELECTRIC HIGH SPEED MOTOR & VARIOUS STERILE & NON STERILE ACCESSORIES Proprietary Device Name: MIDAS REX LEGENDS EHS SYSTEM Registered Establishment Name: MEDTRONIC POWERED SURGICAL SOLUTIONS. |
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Classification: SCREW, FIXATION, BONE Generic Device Name: VARIOUS SIZES AND STYLES OF BONE SCREWS Proprietary Device Name: MULTIPLE Registered Establishment Name: CARBOMEDICS, INC.. |
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Classification: PROSTHESIS, UPPER FEMORAL Generic Device Name: VARIOUS SIZES AND STYLES OF STERILE AND NON-STERILE HEMI-ARTHROPLASTY DEVICES Proprietary Device Name: MULTIPLE Registered Establishment Name: CARBOMEDICS, INC.. |
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Classification: POSITIONER, SOCKET Generic Device Name: HEAD REST Proprietary Device Name: PRONE POSITIONER Registered Establishment Name: VOSS MEDICAL PRODUCTS. |
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Classification: INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR AND ACCESSORY/ATTACHMENT Generic Device Name: POWERED HAND INSTRUMENTS Proprietary Device Name: POWERED HAND INSTRUMENTS Registered Establishment Name: SMITH & NEPHEW, INC.. |
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Classification: APPARATUS, TRACTION, NON-POWERED Generic Device Name: HIP DISTRACTION SYSTEM,HARDWARE Proprietary Device Name: HIP DISTRACTION SYSTEM,HARDWARE Registered Establishment Name: SMITH & NEPHEW, INC.. |
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Classification: COMPONENT, TRACTION, NON-INVASIVE Generic Device Name: NON-INVASIVE TRACTION COMPONENT Proprietary Device Name: NON-INVASIVE TRACTION COMPONENT Registered Establishment Name: SMITH & NEPHEW, INC.. |
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Classification: ARTHROSCOPE Generic Device Name: DYONICS EP-1 SHAVER SYSTEM Proprietary Device Name: DYONICS EP-1 SHAVER SYSTEM Registered Establishment Name: SMITH & NEPHEW, INC.. |
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Classification: HALTER, HEAD, TRACTION Generic Device Name: VARIOUS MODEL OF HEAD HALTERS Proprietary Device Name: HEAD HALTER Registered Establishment Name: TARTAN ORTHOPEDICS, LTD.. |
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Classification: UNIT, TRACTION, HIP, NON-POWERED, NON-PENETRATING Generic Device Name: PELVIC TRACTION BELT Proprietary Device Name: PELVIC TRACTION BELT Registered Establishment Name: TARTAN ORTHOPEDICS, LTD.. |
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Classification: BELT, PELVIC, TRACTION Generic Device Name: PELVIC TRACTION BELT Proprietary Device Name: PELVIC TRACTION BELT Registered Establishment Name: TARTAN ORTHOPEDICS, LTD.. |
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Classification: APPARATUS, TRACTION, NON-POWERED Generic Device Name: BUCKS TRACTION Proprietary Device Name: BUCKS TRACTION Registered Establishment Name: TARTAN ORTHOPEDICS, LTD.. |
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Classification: SCISSORS, ORTHOPEDIC, SURGICAL Generic Device Name: SCISSORS Proprietary Device Name: SCISSORS Registered Establishment Name: SONTEC INSTRUMENTS, INC.. |
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Classification: STRIPPER, SURGICAL Registered Establishment Name: SONTEC INSTRUMENTS, INC.. |
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Classification: ARTHROSCOPE Registered Establishment Name: SONTEC INSTRUMENTS, INC.. |
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Classification: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Registered Establishment Name: SONTEC INSTRUMENTS, INC.. |
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Classification: GAUGE, DEPTH Generic Device Name: DEPTH GAUGE Proprietary Device Name: DEPTH GAUGE Registered Establishment Name: SONTEC INSTRUMENTS, INC.. |
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Classification: WASHER, BOLT NUT Registered Establishment Name: SONTEC INSTRUMENTS, INC.. |
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Classification: RONGEUR Generic Device Name: RONGEUR Proprietary Device Name: RONGEUR Registered Establishment Name: SONTEC INSTRUMENTS, INC.. |
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Classification: SCREW, FIXATION, BONE Registered Establishment Name: SONTEC INSTRUMENTS, INC.. |
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Classification: STARTER, BONE SCREW Registered Establishment Name: SONTEC INSTRUMENTS, INC.. |
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Classification: AWL Registered Establishment Name: SONTEC INSTRUMENTS, INC.. |
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Classification: TREPHINE Generic Device Name: TREPHINE Proprietary Device Name: TREPINE Registered Establishment Name: SONTEC INSTRUMENTS, INC.. |
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Classification: TAP, BONE Registered Establishment Name: SONTEC INSTRUMENTS, INC.. |
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Classification: PASSER, WIRE, ORTHOPEDIC Registered Establishment Name: SONTEC INSTRUMENTS, INC.. |
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Classification: TWISTER, WIRE Registered Establishment Name: SONTEC INSTRUMENTS, INC.. |
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Classification: CERCLAGE, FIXATION Registered Establishment Name: SONTEC INSTRUMENTS, INC.. |
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Classification: WIRE, SURGICAL Registered Establishment Name: SONTEC INSTRUMENTS, INC.. |
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Classification: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Registered Establishment Name: SONTEC INSTRUMENTS, INC.. |
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Classification: GUIDE, DRILL, LIGAMENT Generic Device Name: GUIDE,DRILL,LIGAMENT Proprietary Device Name: GUIDE,DRILL,LIGAMENT Registered Establishment Name: SONTEC INSTRUMENTS, INC.. |
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Classification: STRIPPER, SURGICAL Generic Device Name: TENDON STRIPPERS Proprietary Device Name: TENDON STRIPPERS Registered Establishment Name: KING TOOL, INC.. |
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