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US Food and Drug Administration (FDA) - Orthopedic Devices Registration
FDA Registered Orthopedic Devices - Updated May 2006

What Is Medical Device Listing?

Most medical device establishments required to register with FDA must also identify to FDA the devices they have in commercial distribution including devices produced exclusively for export. This process is known as medical device listing and is a means of keeping FDA advised of the generic category(s) of devices an establishment is manufacturing or marketing. 		FDA Devices
FDA Devices
FDA Devices
FDA Devices


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Classification:   PROSTHESIS, WRIST, CONSTRAINED, METAL
Generic Device Name:   WRIST SPLINT
Proprietary Device Name:   PROSTHESIS, WRIST, CONSTRAINED, METAL
Registered Establishment Name:  BANYAN HEALTH CARE PRODUCTS, INC..
Classification:   TEMPLATE
Generic Device Name:   SURGICAL TEMPLATES
Proprietary Device Name:   SURGIGUIDE
Registered Establishment Name:  MATERIALISE N.V..
Classification:   ARTHROSCOPE
Generic Device Name:   ARTHROSCOPE
Proprietary Device Name:   ARTHROSCOPE
Registered Establishment Name:  MEDIVISION, INC..
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  KOSHIYA CO., LTD..
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   SCISSORS
Proprietary Device Name:   ALBER
Registered Establishment Name:  ALBER MEDIZINTECHNIK.
Classification:   HOLDER, NEEDLE; ORTHOPEDIC
Generic Device Name:   VARIOUS TYPES OF ORTHOPEDIC NEEDLE HOLDERS
Proprietary Device Name:   MULTIPLE, PRIVATE LABEL
Registered Establishment Name:  ALBER MEDIZINTECHNIK.
Classification:   RONGEUR
Generic Device Name:   VARIOUS TYPE OF BONE RONGEURS
Proprietary Device Name:   BONE RONGEURS
Registered Establishment Name:  ALBER MEDIZINTECHNIK.
Classification:   RONGEUR
Generic Device Name:   RONGEUR
Proprietary Device Name:   RONGEUR
Registered Establishment Name:  ARNOLD MEDIZINTECHNIK GMBH.
Classification:   CUTTER, WIRE
Generic Device Name:   CUTTER, WIRE
Proprietary Device Name:   CUTTER, WIRE
Registered Establishment Name:  ARNOLD MEDIZINTECHNIK GMBH.
Classification:   PROSTHESIS, HIP, SEMI-CONSTRAINED (METAL UNCEMENTED ACETABULAR COMPONENT)
Generic Device Name:   BIPOLAR HEAD
Proprietary Device Name:   PROSTHESIS, HIP, SEMI-CONSTRAINED (METAL UNCEMENTED ACETABULAR COMPONENT)
Registered Establishment Name:  BERKELEY ORTHOPEDICS LTD..
Classification:   GONIOMETER, AC-POWERED
Generic Device Name:   BACK MOTION MONITOR
Proprietary Device Name:   ISOTECHNOLOGIES BACKTRACKER & BACKWORKS SOFTWARE
Registered Establishment Name:  INTERLOGICS, INC..
Classification:   MIXER, CEMENT, FOR CLINICAL USE
Generic Device Name:   VARIOUS MIXING BOWLS
Proprietary Device Name:   PAC-DENT SILICONE MIXING BOWLS
Registered Establishment Name:  PAC-DENT INTL., INC..
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   REMOVER OF DAMAGED SCREWS
Proprietary Device Name:   SCREW REMOVER
Registered Establishment Name:  MEDEX MARKETING, INC..
Classification:   DYNAMOMETER, NONPOWERED
Generic Device Name:   GRIP DYNAMOMETER (TKK 5001 GRIP A)
Proprietary Device Name:   T.K.K.
Registered Establishment Name:  TAKEI SCIENTIFIC INSTRUMENTS CO., LTD..
Classification:   BELT, PELVIC, TRACTION
Generic Device Name:   PELVIC TRACTION BELT, PELVIC TRACTION KIT, SKIN TRACTION KIT
Proprietary Device Name:   NET, NEUTRAL, OTHER
Registered Establishment Name:  NARANG MEDICAL, LTD..
Classification:   APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
Generic Device Name:   ORTHOPAEDIC IMPLANTS & INSTRUMENTS
Proprietary Device Name:   NET, NEUTRAL, OTHER
Registered Establishment Name:  NARANG MEDICAL, LTD..
Classification:   DEVICE, FIXATION, PROXIMAL FEMORAL, IMPLANT
Generic Device Name:   ORTHOPAEDIC IMPLANTS & INSTRUMENTS
Proprietary Device Name:   NET, NEUTRAL, OTHER
Registered Establishment Name:  NARANG MEDICAL, LTD..
Classification:   NAIL, FIXATION, BONE, METALLIC
Generic Device Name:   K.NAILS
Proprietary Device Name:   NET, NEUTRAL, OTHER
Registered Establishment Name:  NARANG MEDICAL, LTD..
Classification:   PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS CEMENTED, OSTEOPHILIC FINISH
Generic Device Name:   HIP PROSTHESIS
Proprietary Device Name:   NET, NEUTRAL, OTHER
Registered Establishment Name:  NARANG MEDICAL, LTD..
Classification:   SYSTEM, EXTERNAL FIXATOR (WITH METALLIC INVASIVE COMPONENTS)
Generic Device Name:   EXTERNAL FIXATOR
Proprietary Device Name:   NET, NEUTRAL, OTHER
Registered Establishment Name:  NARANG MEDICAL, LTD..
Classification:   SCREW, FIXATION, BONE, NON-SPINAL, METALLIC
Generic Device Name:   SCREWS
Proprietary Device Name:   NET, NEUTRAL, OTHER
Registered Establishment Name:  NARANG MEDICAL, LTD..
Classification:   IMPLANT, FIXATION DEVICE, CONDYLAR PLATE
Generic Device Name:   ORTHOPAEDIC IMPLANTS
Proprietary Device Name:   NET, NEUTRAL, OTHER
Registered Establishment Name:  NARANG MEDICAL, LTD..
Classification:   PLATE, FIXATION, BONE, NON-SPINAL, METALLIC
Generic Device Name:   FRAGMENT PLATES, PLATES FOR 4.5MM & 6.5MM SCREWS
Proprietary Device Name:   NET, NEUTRAL, OTHER
Registered Establishment Name:  NARANG MEDICAL, LTD..
Classification:   CUTTER, WIRE
Generic Device Name:   WIRE CUTTER
Proprietary Device Name:   AESCULAP
Registered Establishment Name:  NOVOPRO MEDICAL.
Classification:   AWL
Generic Device Name:   AWL
Proprietary Device Name:   AESCULAP
Registered Establishment Name:  NOVOPRO MEDICAL.
Classification:   ARTHROSCOPE
Generic Device Name:   ARTHROSCOPY INSTRUMENTS
Proprietary Device Name:   N/A
Registered Establishment Name:  STERILMED, INC..
Classification:   BIT, DRILL
Generic Device Name:   DRILL BIT
Proprietary Device Name:   N/A
Registered Establishment Name:  STERILMED, INC..
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   SCISSORS
Proprietary Device Name:   SCISSORS
Registered Establishment Name:  DEWAL SURGICAL CO..
Classification:   GENERATOR,SHOCK-WAVE,(FOR PAIN RELIEF)
Generic Device Name:   ORTHOPEDIC EXTRACORPOREAL SHOCK WAVE THERAPY
Proprietary Device Name:   OSSATRON OSA 120
Registered Establishment Name:  HEALTHTRONICS GMBH.
Classification:   ARTHROSCOPE
Generic Device Name:   SUTURE PASSER AND CANNULAS
Proprietary Device Name:   SHARPSHOTTER AND ACCESSORIES
Registered Establishment Name:  REGEN BIOLOGICS, INC..
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   VARIOUS TYPES OF SCISSORS
Proprietary Device Name:   SCISSORS (MULTIPLE BRANDS)
Registered Establishment Name:  MICROMECH INSTRUMENT CORPORATION.
Classification:   RONGEUR
Generic Device Name:   VARIOUS TYPES OF RONGEURS
Proprietary Device Name:   RONGEUR (MULTIPLE BRANDS)
Registered Establishment Name:  MICROMECH INSTRUMENT CORPORATION.
Classification:   FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
Generic Device Name:   BONE ANCHOR SYSTEM
Proprietary Device Name:   BONE ANCHOR SYSTEM III(BAS III)
Registered Establishment Name:  BOSTON SCIENTIFIC CORP..
Classification:   PLATE, FIXATION, BONE
Generic Device Name:   VARIOUS
Proprietary Device Name:   ORTHOPAEDIC PLATE SYSTEM
Registered Establishment Name:  APOTHECARIES SUNDRIES MFG. CO..
Classification:   SCREW, FIXATION, BONE
Generic Device Name:   VARIOUS
Proprietary Device Name:   ORTHOPAEDIC SCREW SYSTEM
Registered Establishment Name:  APOTHECARIES SUNDRIES MFG. CO..
Classification:   ARTHROSCOPE
Generic Device Name:   VARIOUS ARTHROSCOPIC ACCESSORIES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ENDIUS, INC..
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   TREPHINES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ENDIUS, INC..
Classification:   APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
Generic Device Name:   ANTERIOR CERVICAL PLATING SYSTEM
Proprietary Device Name:   WINDOW CERVICAL STABILIZATION SYSTEM
Registered Establishment Name:  ENDIUS, INC..
Classification:   APPLIANCE, FIXATION, SPINAL INTERLAMINAL
Generic Device Name:   PEDICLE SCREW SYSTEM
Proprietary Device Name:   SPINAL FIXATION SYSTEM, MULTIPLE
Registered Establishment Name:  ENDIUS, INC..
Classification:   ORTHOSIS, SPONDYLOISTHESIS SPINAL FIXATION
Generic Device Name:   PEDICLE SCREW SYSTEM
Proprietary Device Name:   SPINAL FIXATION SCREW SYSTEM, MULTIPLE
Registered Establishment Name:  ENDIUS, INC..

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Last Modified: 29 April 2006
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