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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:   PLATE, FIXATION, BONE
Generic Device Name:   BAXTER ARTHROSCOPIC SHAVER
Proprietary Device Name:   POWERCUT GOLD SURGICAL SYSTEM
Registered Establishment Name:  ALTAIR INSTRUMENTS, INC..
Classification:   TEMPLATE
Generic Device Name:   SIZER TEMPLATE
Proprietary Device Name:   MCGHAN SIZER TEMPLATES
Registered Establishment Name:  INAMED CORPORATION.
Classification:   BONE MILL
Generic Device Name:   BONE MILL
Registered Establishment Name:  TRACER DESIGNS, INC..
Classification:   INSTRUMENT, SURGICAL, ORTHOPEDIC, PNEUMATIC POWERED & ACCESSORY/ATTACHMENT
Generic Device Name:   SURGICAL INSTRUMENT SYSTEM
Proprietary Device Name:   MICRO LINE SURGICAL INSTRUMENT SYSTEM
Registered Establishment Name:  BRASSELER USA, MEDICAL L.L.C..
Classification:   INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
Generic Device Name:   SURGICAL INSTRUMENT SYSTEMS
Proprietary Device Name:   VARIOUS SURGICAL INSTRUMENT SYSTEMS
Registered Establishment Name:  BRASSELER USA, MEDICAL L.L.C..
Classification:   PIN, FIXATION, THREADED
Generic Device Name:   THREADED K-WIRE,STEINMAN PINS
Proprietary Device Name:   THREADED K-WIRE,STEINMAN PINS
Registered Establishment Name:  BRASSELER USA, MEDICAL L.L.C..
Classification:   INSTRUMENT, SURGICAL, SONIC AND ACCESSORY/ATTACHMENT
Generic Device Name:   SURGICAL SAW BLADES
Proprietary Device Name:   SURGICAL SAW BLADES
Registered Establishment Name:  BRASSELER USA, MEDICAL L.L.C..
Classification:   PIN, FIXATION, SMOOTH
Generic Device Name:   SMOOTH K-WIRE,STEINMAN PINS
Proprietary Device Name:   SMOOTH K-WIRE,STEINMAN PINS
Registered Establishment Name:  BRASSELER USA, MEDICAL L.L.C..
Classification:   INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
Generic Device Name:   DERMABRADER 1 HAND ENGINE
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  BYRON MEDICAL.
Classification:   MONITOR, PRESSURE, INTRACOMPARTMENTAL
Generic Device Name:   MONITOR AND STERILE DISPOSABLES TO MONITOR INTRACOMPARTMENTAL PRESSURE
Proprietary Device Name:   PRESSURE SENSE INTRACOMPARTMENTAL PRESSURE MONITOR
Registered Establishment Name:  AVAIL MEDICAL PRODUCTS, INC..
Classification:   DYNAMOMETER, NONPOWERED
Generic Device Name:   DYNAMOMETER, PHYSICAL MEDICINE
Proprietary Device Name:   ARCON; GRIP STRENGHT
Registered Establishment Name:  VERNOVA, INC..
Classification:   GONIOMETER, NONPOWERED
Generic Device Name:   GONIOMETER, ORTHOPEDIC
Proprietary Device Name:   ARCON ROM
Registered Establishment Name:  VERNOVA, INC..
Classification:   SCREW, FIXATION, BONE
Generic Device Name:   CANNULATED CANCELLOUS BONE SCREW & CORTICAL SCREWS
Proprietary Device Name:   6.5mm CANNULATED SCREW; 4.5 CORTICAL SCREW
Registered Establishment Name:  ALPHATEC SPINE, INC..
Classification:   NAIL, FIXATION, BONE
Generic Device Name:   COMPRESSION HIP SCREW
Proprietary Device Name:   MODULAR HIP SCREW
Registered Establishment Name:  ALPHATEC SPINE, INC..
Classification:   PLATE, FIXATION, BONE
Generic Device Name:   4.5 COMPRESSION PLATES
Proprietary Device Name:   DYNAMIC COMPRESSION PLATES
Registered Establishment Name:  ALPHATEC SPINE, INC..
Classification:   APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
Generic Device Name:   DELTALOC ANTERIOR CERVICAL PLATE SYSTEM
Proprietary Device Name:   DELTALOC ANTERIOR CERVICAL PLATE SYSTEM
Registered Establishment Name:  ALPHATEC SPINE, INC..
Classification:   APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
Generic Device Name:   ALPHATEC EXTERNAL FIXATION SYSTEM
Proprietary Device Name:   TOSIC EXTERNAL FIXATION SYSTEM
Registered Establishment Name:  ALPHATEC SPINE, INC..
Classification:   ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Generic Device Name:   ALPHATEC INTRAMEDALLARY NAIL SYSTEM
Proprietary Device Name:   TITAN INTRAMEDYLLARY NAIL SYSTEM
Registered Establishment Name:  ALPHATEC SPINE, INC..
Classification:   PIN, FIXATION, THREADED
Generic Device Name:   ALPHATEC EXTERNAL FIXATION HYBRID SYSTEM
Proprietary Device Name:   TASIC EXTERNAL FIXATION HYBRID SYSTEM
Registered Establishment Name:  ALPHATEC SPINE, INC..
Classification:   APPLIANCE, FIXATION, SPINAL INTERLAMINAL
Generic Device Name:   PEDICLE SCREW SYSTEM
Proprietary Device Name:   ZODIAC POLYAXIAL PEDICLE SCREW SYSTEM
Registered Establishment Name:  ALPHATEC SPINE, INC..
Classification:   ORTHOSIS, SPONDYLOISTHESIS SPINAL FIXATION
Generic Device Name:   PEDICLE SCREW SPINAL SYSTEM
Proprietary Device Name:   ZODIAC POLYAXIAL PEDICLE SCREW SYSTEM
Registered Establishment Name:  ALPHATEC SPINE, INC..
Classification:   ORTHOSIS, SPINAL PEDICLE FIXATION
Generic Device Name:   PEDICLE SCREW SYSTEM
Proprietary Device Name:   ZODIAC POLYAXIAL PEDICLE SCREW SYSTEM
Registered Establishment Name:  ALPHATEC SPINE, INC..
Classification:   SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
Generic Device Name:   VETEBRAL BODY REPLACEMENT DEVICE
Proprietary Device Name:   NOVEL VBR SYSTEM
Registered Establishment Name:  ALPHATEC SPINE, INC..
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Proprietary Device Name:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Registered Establishment Name:  SAWYER PRODUCTS, INC..
Classification:   APPARATUS, TRACTION, NON-POWERED
Generic Device Name:   OXYGEN CART, O2 CARRIER
Proprietary Device Name:   EAGLE HEALTH SUPPLIES
Registered Establishment Name:  EAGLE HEALTH SUPPLIES, INC..
Classification:   APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
Generic Device Name:   ANTERIOR FIXATION DEVICES
Proprietary Device Name:   MULTIPLE, TSRH, CD HORIZON, DYNALOK, ATLANTIS, ZPLATE-ATL, PYRAMID, VERTE-STACK
Registered Establishment Name:  MEDTRONIC PUERTO RICO OPERATIONS CO.,MED REL.
Classification:   DEVICE, FIXATION, PROXIMAL FEMORAL, IMPLANT
Generic Device Name:   MULTIPLE (PROXIMAL FEMORAL FIXATION DEVICES, NAILS, PLATES, SCREWS, PINS)
Proprietary Device Name:   MULTIPLE (PROXIMAL FEMORAL FIXATION DEVICES, NAILS, PLATES, SCREWS, PINS)
Registered Establishment Name:  MEDTRONIC PUERTO RICO OPERATIONS CO.,MED REL.
Classification:   ARTHROSCOPE
Generic Device Name:   ARTHROSCOPE
Proprietary Device Name:   VARIOUS ARTHROSCOPES AND ACCESSORIES
Registered Establishment Name:  ACMI CORPORATION.
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   MULTIPLE
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SCANLAN INTERNATIONAL, INC..
Classification:   PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
Generic Device Name:   MULTIPLE
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SCANLAN INTERNATIONAL, INC..
Classification:   RONGEUR
Generic Device Name:   MULTIPLE
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SCANLAN INTERNATIONAL, INC..
Classification:   CUTTER, WIRE
Generic Device Name:   NO COMMON NAME LISTED
Proprietary Device Name:   SCANLAN GIGLI WIRE CUTTER
Registered Establishment Name:  SCANLAN INTERNATIONAL, INC..
Classification:   APPARATUS, TRACTION, NON-POWERED
Generic Device Name:   VARIOUS TRACTION KITS AND ACCESSORIES
Proprietary Device Name:   CERVICAL TRACTION KIT; BED TRACTION FRAME; TRACTION CORD
Registered Establishment Name:  BIRD & CRONIN, INC..
Classification:   SPLINT, TRACTION
Generic Device Name:   BUCKS TRACTION BOOT
Proprietary Device Name:   BUCKS TRACTION BOOT
Registered Establishment Name:  BIRD & CRONIN, INC..
Classification:   BELT, PELVIC, TRACTION
Generic Device Name:   PELVIC TRACTION BELT
Proprietary Device Name:   PELVIC TRACTION BELT
Registered Establishment Name:  BIRD & CRONIN, INC..
Classification:   APPARATUS, TRACTION, NON-POWERED
Generic Device Name:   WEIGHT
Proprietary Device Name:   TRACTION ACCESSORIES
Registered Establishment Name:  THE BREWER CO..
Classification:   CALIPER
Generic Device Name:   VARIOUS TYPES OF CALIPERS
Proprietary Device Name:   CALIPER
Registered Establishment Name:  RADIATION PRODUCTS DESIGN, INC..
Classification:   PROTRACTOR
Generic Device Name:   VARIOUS TYPES OF BREAST BRIDGE ANGULATION DEVICES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  RADIATION PRODUCTS DESIGN, INC..
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   SCISSORS
Proprietary Device Name:   CHROME SAFETY SCISSORS/BANDAGE/FOLDING
Registered Establishment Name:  APOTHECARY PRODUCTS, INC..
Classification:   KNIFE, ORTHOPEDIC
Generic Device Name:   COMFORT GRIP KNIFE
Proprietary Device Name:   AIDS FOR INDEPENDENT LIVING
Registered Establishment Name:  APOTHECARY PRODUCTS, INC..

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Last Modified: 29 April 2006
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