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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: BIT, DRILL Generic Device Name: BIT, DRILL Proprietary Device Name: WRISTJACK PRE-DRILL KIT Registered Establishment Name: HAND BIOMECHANICS LAB, INC.. |
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Classification: PIN, FIXATION, THREADED Generic Device Name: PIN, FIXATION, THREADED Proprietary Device Name: PIN, FIXATION, THREADED Registered Establishment Name: HAND BIOMECHANICS LAB, INC.. |
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Classification: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT Generic Device Name: EXTERNAL WRIST FIXATOR Proprietary Device Name: WRISTJACK ORIF SYSTEM Registered Establishment Name: HAND BIOMECHANICS LAB, INC.. |
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Classification: SPLINT, TRACTION Generic Device Name: TRACTION SPLINT Proprietary Device Name: BUCK'S TRACTION SPLINT Registered Establishment Name: ORTHOPEDIC SYSTEMS, INC.. |
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Classification: HALTER, HEAD, TRACTION Generic Device Name: STANDARD HEAD HALTERS INCL. DISPOSIBLES Registered Establishment Name: ORTHOPEDIC SYSTEMS, INC.. |
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Classification: BELT, PELVIC, TRACTION Generic Device Name: DISPOSABLE PELVIC TRACTION BELT Registered Establishment Name: ORTHOPEDIC SYSTEMS, INC.. |
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Classification: APPARATUS, TRACTION, NON-POWERED Generic Device Name: PELVIC TRACTION APPARATUS Proprietary Device Name: PELVIC SURGERY KIT Registered Establishment Name: ORTHOPEDIC SYSTEMS, INC.. |
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Classification: SPLINT, TRACTION Generic Device Name: VARIOUS MODELS/SIZES EMERGENCY TRACTION SPLINTS Proprietary Device Name: MULTILPLE Registered Establishment Name: MINTO RESEARCH & DEVELOPMENT, INC.. |
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Classification: PIN, FIXATION, THREADED Generic Device Name: SNAP PIN Proprietary Device Name: SNAP FIXATION PIN Registered Establishment Name: SGARLATO LABORATORIES, INC.. |
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Classification: PROSTHESIS, TOE, CONSTRAINED, POLYMER Generic Device Name: TOE IMPLANTS, SILCONE Proprietary Device Name: GAIT IMPLANT, SHIP IMPLANT Registered Establishment Name: SGARLATO LABORATORIES, INC.. |
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Classification: PROSTHESIS, LIGAMENT, PTFE Generic Device Name: ENDOGRADE Proprietary Device Name: ENDOGRADE Registered Establishment Name: H.S. INTL. CO., INC.. |
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Classification: APPARATUS, TRACTION, NON-POWERED Generic Device Name: TRACTION SPLINT Proprietary Device Name: PIVOTTRAC Registered Establishment Name: REEL RESEARCH AND DEVELOPMENT, INC.. |
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Classification: GONIOMETER, NONPOWERED Generic Device Name: GONIOMETER Proprietary Device Name: LEIGHTON FLEXOMETER Registered Establishment Name: LEIGHTON FLEXOMETER. |
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Classification: INSTRUMENT, CAST APPLICATION/REMOVAL, MANUAL Generic Device Name: KRONNER FOOT CASTING STAND Proprietary Device Name: KRONNER FOOT CASTING STAND Registered Establishment Name: KRONNER PROTOTYPES, INC.. |
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Classification: BELT, PELVIC, TRACTION Generic Device Name: PELVIC TRACTION BELT Proprietary Device Name: PELVIC BELT Registered Establishment Name: SHAMROCK MEDICAL, INC.. |
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Classification: APPARATUS, TRACTION, NON-POWERED Generic Device Name: PELVIC/CERVICAL TRACTION Proprietary Device Name: LUMBO-90; C-FLEX; ECONO-SERV Registered Establishment Name: SHAMROCK MEDICAL, INC.. |
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Classification: HALTER, HEAD, TRACTION Generic Device Name: CERVICAL TRACTION HALTER Proprietary Device Name: HEAD HALTER Registered Establishment Name: SHAMROCK MEDICAL, INC.. |
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Classification: COMPONENT, TRACTION, NON-INVASIVE Generic Device Name: PELVIC SLING, CIRCUMFERENTIAL SACROILIAC SLING ORTHOSIS Proprietary Device Name: SAM SLING Registered Establishment Name: THE SEABERG COMPANY, INC.. |
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Classification: COMPONENT, TRACTION, NON-INVASIVE Generic Device Name: NON-INVASIVE LUMBAR TRACTION COMPONENT Proprietary Device Name: GRAVITRAK Registered Establishment Name: SISKIYOU PACIFIC, INC.. |
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Classification: SCISSORS, ORTHOPEDIC, SURGICAL Generic Device Name: VARIOUS Proprietary Device Name: MULTIPLE Registered Establishment Name: RICHARD WOLF GMBH. |
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Classification: PROBE Generic Device Name: PROBE Proprietary Device Name: MULTIPLE Registered Establishment Name: RICHARD WOLF GMBH. |
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Classification: INSTRUMENT, SURGICAL, ORTHOPEDIC, PNEUMATIC POWERED & ACCESSORY/ATTACHMENT Generic Device Name: PNEUMATIC POWERED ORTHPEDIC INSTRUMENT Proprietary Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, PNEUMATIC POWERED & ACCESSORY/ATTACHMENT Registered Establishment Name: RICHARD WOLF GMBH. |
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Classification: ARTHROSCOPE Generic Device Name: ARTHROSCOPE Proprietary Device Name: ARTHROSCOPE Registered Establishment Name: RICHARD WOLF GMBH. |
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Classification: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT Generic Device Name: INTRA-ARTICULATED ARTHROSCOPIC POWER SYSTEM Proprietary Device Name: INTRA-ARTICULATED ARTHROSCOPIC POWER SYSTEM Registered Establishment Name: RICHARD WOLF GMBH. |
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Classification: IMPACTOR Generic Device Name: IMPACTOR Proprietary Device Name: IMPACTOR Registered Establishment Name: RICHARD WOLF GMBH. |
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Classification: EXTRACTOR Generic Device Name: EXTRACTOR Proprietary Device Name: EXTRACTOR Registered Establishment Name: RICHARD WOLF GMBH. |
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Classification: PUSHER, SOCKET Generic Device Name: PUSHER Proprietary Device Name: PUSHER Registered Establishment Name: RICHARD WOLF GMBH. |
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Classification: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Generic Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Proprietary Device Name: ORTHOPEDIC SURGICAL INSTRUMENT Registered Establishment Name: RICHARD WOLF GMBH. |
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Classification: GUIDE, DRILL, LIGAMENT Generic Device Name: DRILL GUIDE Proprietary Device Name: ACL INSTRUMENT Registered Establishment Name: RICHARD WOLF GMBH. |
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Classification: RONGEUR Generic Device Name: VARIOUS TYPES OF RONGEURS Proprietary Device Name: RONGEUR (MULTIPLE BRANDS) Registered Establishment Name: RICHARD WOLF GMBH. |
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Classification: SCISSORS, ORTHOPEDIC, SURGICAL Generic Device Name: VARIOUS Proprietary Device Name: MULTIPLE Registered Establishment Name: RICHARD WOLF MEDICAL INSTRUMENTS CORP.. |
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Classification: PROBE Generic Device Name: PROBE Proprietary Device Name: MULTIPLE Registered Establishment Name: RICHARD WOLF MEDICAL INSTRUMENTS CORP.. |
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Classification: INSTRUMENT, SURGICAL, ORTHOPEDIC, PNEUMATIC POWERED & ACCESSORY/ATTACHMENT Generic Device Name: PNEUMATIC POWERED ORTHPEDIC INSTRUMENT Proprietary Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, PNEUMATIC POWERED & ACCESSORY/ATTACHMENT Registered Establishment Name: RICHARD WOLF MEDICAL INSTRUMENTS CORP.. |
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Classification: ARTHROSCOPE Generic Device Name: ARTHROSCOPE Proprietary Device Name: ARTHROSCOPE Registered Establishment Name: RICHARD WOLF MEDICAL INSTRUMENTS CORP.. |
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Classification: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT Generic Device Name: INTRA-ARTICULATED ARTHROSCOPIC POWER SYSTEM Proprietary Device Name: INTRA-ARTICULATED ARTHROSCOPIC POWER SYSTEM Registered Establishment Name: RICHARD WOLF MEDICAL INSTRUMENTS CORP.. |
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Classification: IMPACTOR Generic Device Name: IMPACTOR Proprietary Device Name: IMPACTOR Registered Establishment Name: RICHARD WOLF MEDICAL INSTRUMENTS CORP.. |
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Classification: EXTRACTOR Generic Device Name: EXTRACTOR Proprietary Device Name: EXTRACTOR Registered Establishment Name: RICHARD WOLF MEDICAL INSTRUMENTS CORP.. |
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Classification: PUSHER, SOCKET Generic Device Name: PUSHER Proprietary Device Name: PUSHER Registered Establishment Name: RICHARD WOLF MEDICAL INSTRUMENTS CORP.. |
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Classification: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Generic Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Proprietary Device Name: ORTHOPEDIC SURGICAL INSTRUMENT Registered Establishment Name: RICHARD WOLF MEDICAL INSTRUMENTS CORP.. |
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Classification: GUIDE, DRILL, LIGAMENT Generic Device Name: DRILL GUIDE Proprietary Device Name: ACL INSTRUMENT Registered Establishment Name: RICHARD WOLF MEDICAL INSTRUMENTS CORP.. |
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