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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:   INSTRUMENT, COMPRESSION
Generic Device Name:   PLATE AND SCREW COMPRESSION DEVICES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  MEDTRONIC SOFAMOR DANEK USA, INC..
Classification:   SCREWDRIVER
Generic Device Name:   SCREWDRIVER, ORTHOPEDIC
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  MEDTRONIC SOFAMOR DANEK USA, INC..
Classification:   TAMP
Generic Device Name:   MULTPLE TAMPS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  MEDTRONIC SOFAMOR DANEK USA, INC..
Classification:   ACCESSORIES,ARTHROSCOPIC
Generic Device Name:   ARTHROSCOPE
Proprietary Device Name:   ARTHROSCOPE
Registered Establishment Name:  MEDTRONIC SOFAMOR DANEK USA, INC..
Classification:   INSTRUMENT, BENDING OR CONTOURING
Generic Device Name:   VARIOUS ROD BENDERS
Proprietary Device Name:   ROD BENDER
Registered Establishment Name:  MEDTRONIC SOFAMOR DANEK USA, INC..
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 SOFAMOR DANEK USA, INC..
Classification:   GAUGE, DEPTH
Generic Device Name:   MULTIPLE (DEPTH GAUGES)
Proprietary Device Name:   MULTIPLE (DEPTH GAUGES)
Registered Establishment Name:  MEDTRONIC SOFAMOR DANEK USA, INC..
Classification:   FILLER, BONE VOID, CALCIUM COMPOUND
Generic Device Name:   VARIOUS SHAPES AND SIZES OF STERILE BONE GRAFT MATERIAL
Proprietary Device Name:   GENEROS SCAFFOLD FOAM BONE GRAFT MATERIAL
Registered Establishment Name:  BERKELEY ADVANCED BIOMATERIALS, INC..
Classification:   COMPONENT, CAST
Generic Device Name:   CAST COVER
Proprietary Device Name:   CLARE SHIELD
Registered Establishment Name:  CAST SHIELD INTERNATIONAL, INC..
Classification:   SCREWDRIVER
Generic Device Name:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Proprietary Device Name:   SCREWDRIVER, HANDLE ONLY
Registered Establishment Name:  SMALL BONE INNOVATIONS, INC..
Classification:   CUTTER, WIRE
Generic Device Name:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Proprietary Device Name:   EASY CUT WIRE & PIN CUTTER
Registered Establishment Name:  SMALL BONE INNOVATIONS, INC..
Classification:   BRACE, DRILL
Generic Device Name:   BRACE, DRILL
Proprietary Device Name:   TAP HANDLE, A/O STYLE
Registered Establishment Name:  SMALL BONE INNOVATIONS, INC..
Classification:   COUNTERSINK
Generic Device Name:   COUNTERSINK
Proprietary Device Name:   COUNTERSINK
Registered Establishment Name:  SMALL BONE INNOVATIONS, INC..
Classification:   BIT, DRILL
Generic Device Name:   BIT, DRILL
Proprietary Device Name:   DRILL GUIDE
Registered Establishment Name:  SMALL BONE INNOVATIONS, INC..
Classification:   APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
Generic Device Name:   SINGLE/MULTIPLE COMPONENT METALLIC BONE FIXATION APPLIANCES AND ACCESSORIES
Proprietary Device Name:   RING FIXATOR
Registered Establishment Name:  SMALL BONE INNOVATIONS, INC..
Classification:   ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Generic Device Name:   INTRAMEDULLARY FIXATION ROD
Proprietary Device Name:   IFO SYSTEM
Registered Establishment Name:  SMALL BONE INNOVATIONS, INC..
Classification:   PLATE, FIXATION, BONE
Generic Device Name:   INTERNAL FIXATION SYSTEM
Proprietary Device Name:   SBI HAND FIXATION SYSTEM
Registered Establishment Name:  SMALL BONE INNOVATIONS, INC..
Classification:   SCREW, FIXATION, BONE
Generic Device Name:   INTERNAL FIXATION SYSTEM
Proprietary Device Name:   SBI HAND FIXATION SYSTEM
Registered Establishment Name:  SMALL BONE INNOVATIONS, INC..
Classification:   INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
Generic Device Name:   SURGICAL INSTRUMENT AND ACCESSORIES/ATTACHMENTS
Proprietary Device Name:   COUNTERSINK, 3.75MMX90DG
Registered Establishment Name:  SMALL BONE INNOVATIONS, INC..
Classification:   APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
Generic Device Name:   WRIST FIXATOR
Proprietary Device Name:   CLEAR VIEW
Registered Establishment Name:  RIGID FX ORTHOPEDICS, INCORPORATED.
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   VARIOUS TYPES OF SCISSORS
Proprietary Device Name:   SCISSORS
Registered Establishment Name:  G-P INSTRUMENTS SUPPLY CO..
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   SCISSORS
Proprietary Device Name:   AMERI-TEK INC.
Registered Establishment Name:  AMERI-TEK INC..
Classification:   PROBE
Generic Device Name:   PROBE
Proprietary Device Name:   PROBE
Registered Establishment Name:  AMERI-TEK INC..
Classification:   RONGEUR
Generic Device Name:   RONGEUR
Proprietary Device Name:   RONGEUR
Registered Establishment Name:  AMERI-TEK INC..
Classification:   GONIOMETER, NONPOWERED
Generic Device Name:   LIGMASTER
Proprietary Device Name:   LIGMASTER
Registered Establishment Name:  SPORT TECH, INC..
Classification:   BONE MILL
Generic Device Name:   BONE MILL
Proprietary Device Name:   NOVIOMAGUS BONE MILL
Registered Establishment Name:  SPIERINGS ORTHOPAEDICS B.V..
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   SCISSORS
Proprietary Device Name:   SCISSORS, ORTHOPEDIC, SURGICAL
Registered Establishment Name:  SURGICAL INSTRUMENTS BELGIUM SA.
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   SCISSORS
Proprietary Device Name:   ALLEGRO SURGICAL CORP.
Registered Establishment Name:  ALLEGRO SURGICAL CORP..
Classification:   BONE CEMENT
Generic Device Name:   BONE CEMENT
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ETHICON, DIVISION OF JOHNSON & JOHNSON MEDICAL LTD.
Classification:   RONGEUR
Generic Device Name:   RONGEUR
Proprietary Device Name:   RONGEUR
Registered Establishment Name:  BOB INSTRUMENTS GMBH.
Classification:   INSTRUMENT, CAST APPLICATION/REMOVAL, MANUAL
Generic Device Name:   INSTRUMENT, CAST APPLICATION/REMOVAL, MANUAL
Proprietary Device Name:   INSTRUMENT, CAST APPLICATION/REMOVAL, MANUAL
Registered Establishment Name:  BOB INSTRUMENTS GMBH.
Classification:   APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
Generic Device Name:   PRE-MOLDED PLATES FOR OSTEOTOMIES
Proprietary Device Name:   SURFIX(R) KNEE OSTEOROMY SYSTEM
Registered Establishment Name:  SURFIX TECHNOLOGIES.
Classification:   APPARATUS, TRACTION, NON-POWERED
Generic Device Name:   VARIOUS MODELS OF NON-POWERED TRACTION APPARATUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZHONGSHAN A&E MACHINERY INDUSTRY CO., LTD..
Classification:   APPARATUS, TRACTION, NON-POWERED
Generic Device Name:   APPARATUS, TRACTION, NON-POWERED
Proprietary Device Name:   NECK PRO
Registered Establishment Name:  GILLIAM ENTERPRISES, LLC.
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   SURGICAL ORTHOPEDIC SCISSORS
Proprietary Device Name:   SUN ECHO VARIOUS MODELS OF SURGICAL ORTHOPEDIC SCISSORS
Registered Establishment Name:  SUN ECHO INTL. CO., LTD..
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   SCISSORS
Proprietary Device Name:   CHANDJEE MFG. CO.
Registered Establishment Name:  CHANDJEE MFG. CO..
Classification:   FILLER, BONE VOID, CALCIUM COMPOUND
Generic Device Name:   BONE VOID FILLER, FILLER, BETA-TRICALCIUM PHOSPHATE
Proprietary Device Name:   CERASORB ORTHO
Registered Establishment Name:  CURASAN AG.
Classification:   ORTHOSIS, SPONDYLOISTHESIS SPINAL FIXATION
Generic Device Name:   ROGO ROD SYSTEM
Proprietary Device Name:   ROGOZINSKI SPINAL ROD SYSTEM ROD-TO-BOLT (UNIVERSAL)
Registered Establishment Name:  VERTEBRAL SYSTEMS.
Classification:   APPLIANCE, FIXATION, SPINAL INTERLAMINAL
Generic Device Name:   EMPOWER SCREW
Proprietary Device Name:   EMPOWER ANTERIOR DIRECT SCREWS
Registered Establishment Name:  VERTEBRAL SYSTEMS.
Classification:   APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
Generic Device Name:   EMPOWER SYSTEM
Proprietary Device Name:   EMPOWER THORACOLUMBAR SPINAL ROD SYSTEM
Registered Establishment Name:  VERTEBRAL SYSTEMS.

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Last Modified: 29 April 2006
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