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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:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   ACCESSORY INSTRUMENTS FOR BIONE PLATING SYSTEM, PROVIDED STERILE/NON-STERILE
Proprietary Device Name:   INION CPS INSTRUMENTS
Registered Establishment Name:  INION LTD..
Classification:   SCREW, FIXATION, BONE
Generic Device Name:   BONE FIXATION FASTNER
Proprietary Device Name:   SCREW, FIXATION, BONE (MULTIPLE BRANDS)
Registered Establishment Name:  INION LTD..
Classification:   PLATE, FIXATION, BONE
Generic Device Name:   BONE PLATE
Proprietary Device Name:   INION OTPS
Registered Establishment Name:  INION LTD..
Classification:   PIN, FIXATION, SMOOTH
Generic Device Name:   BONE PIN
Proprietary Device Name:   OTPS BIODEGRADABLE PIN
Registered Establishment Name:  INION LTD..
Classification:   FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
Generic Device Name:   FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
Proprietary Device Name:   INION ANCHRON BIODEGRADABLE ANCHOR SYSTEM
Registered Establishment Name:  INION LTD..
Classification:   APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
Generic Device Name:   SPINAL PLATE, SPINAL SHEET
Proprietary Device Name:   INION S-1 BIODEGRADABLE ACFS
Registered Establishment Name:  INION LTD..
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   ARTHROSCOPIC INSTRUMENTS AND LIGAMENT RECONSTRUCTION ACCESSORIES
Proprietary Device Name:   ATLANTECH
Registered Establishment Name:  ARTHOCARE UK, LTD..
Classification:   BIT, DRILL
Generic Device Name:   DRILLS, CANNULATED
Proprietary Device Name:   ATLANTECH LIGAMENT TUNNEL DRILLS
Registered Establishment Name:  ARTHOCARE UK, LTD..
Classification:   ARTHROSCOPE
Generic Device Name:   ARTHROSCOPES, 2.7 MM AND 4.0 MM
Proprietary Device Name:   ATLANTECH
Registered Establishment Name:  ARTHOCARE UK, LTD..
Classification:   SCREW, FIXATION, BONE
Generic Device Name:   VARIOUS TYPES OF SCREWS
Proprietary Device Name:   BIOLOK SCREWS/ATLANTECH GRAFT FIXATION SCREW
Registered Establishment Name:  ARTHOCARE UK, LTD..
Classification:   HOLDER, NEEDLE; ORTHOPEDIC
Generic Device Name:   NEEDLE HOLDER
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  RAINER ROSENKRANZ CHIRURGISCHE INSTRUMENTE MANUFAC.
Classification:   CUTTER, WIRE
Generic Device Name:   WIRE CUTTER
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  RAINER ROSENKRANZ CHIRURGISCHE INSTRUMENTE MANUFAC.
Classification:   APPLIANCE, FIXATION, SPINAL INTERLAMINAL
Generic Device Name:   SPINAL FIXATION SYSTEM
Proprietary Device Name:   GLOBAL SPINAL FIXATION SYSTEM, SPINAL HOOK SYSTEM
Registered Establishment Name:  U&I CORP..
Classification:   APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
Generic Device Name:   SPINAL FIXATION SYSTEM
Proprietary Device Name:   OPTIMA SPINAL SYSTEM
Registered Establishment Name:  U&I CORP..
Classification:   ORTHOSIS, SPONDYLOISTHESIS SPINAL FIXATION
Generic Device Name:   SPINAL FIXATION SYSTEM
Proprietary Device Name:   OPTIMA SPINAL SYSTEM, GLOBAL SPINAL FIXATION SYSTEM
Registered Establishment Name:  U&I CORP..
Classification:   ORTHOSIS, SPINAL PEDICLE FIXATION
Generic Device Name:   SPINAL FIXATION SYSTEM
Proprietary Device Name:   OPTIMA SPINAL SYSTEM, GLOBAL SPINAL FIXATION SYSTEM
Registered Establishment Name:  U&I CORP..
Classification:   AWL
Generic Device Name:   AWL
Proprietary Device Name:   AWL
Registered Establishment Name:  U&I CORP..
Classification:   INSTRUMENT, COMPRESSION
Generic Device Name:   COMPRESSOR INSTRUMENT
Proprietary Device Name:   COMPRESSOR
Registered Establishment Name:  U&I CORP..
Classification:   TAP, BONE
Generic Device Name:   BONE TAP
Proprietary Device Name:   TAP-4.OMM, TAP-5.OMM, TAP-6.OMM, TAP-7.0MM, TAP-7.5MM, TAP-8.0MM
Registered Establishment Name:  U&I CORP..
Classification:   PROBE
Generic Device Name:   PROBE
Proprietary Device Name:   PROBE, CURVED PROBE
Registered Establishment Name:  U&I CORP..
Classification:   WRENCH
Generic Device Name:   WRENCH
Proprietary Device Name:   TORQUE WRENCH FOR T LINK-COLLET TYPE, AXIAL TORQUE WRENCH, DEROTATOR
Registered Establishment Name:  U&I CORP..
Classification:   FORK
Generic Device Name:   FORK
Proprietary Device Name:   ROD FORK
Registered Establishment Name:  U&I CORP..
Classification:   PUSHER, SOCKET
Generic Device Name:   SOCKET PUSHER
Proprietary Device Name:   ROD PUSHER
Registered Establishment Name:  U&I CORP..
Classification:   INSTRUMENT, BENDING OR CONTOURING
Generic Device Name:   BENDING INSTRUMENT
Proprietary Device Name:   IN-SITU ROD BENDER-RIGHT, IN-SITU ROD BENDER-LEFT
Registered Establishment Name:  U&I CORP..
Classification:   BENDER
Generic Device Name:   ROD BENDER
Proprietary Device Name:   ROD BENDER
Registered Establishment Name:  U&I CORP..
Classification:   SCREWDRIVER
Generic Device Name:   SCREWDRIVER
Proprietary Device Name:   2.5MM HEX DRIVER, POLY SCREW DRIVER, MONO SCREW DRIVER, LARGE POLY SCREW DRIVER,
Registered Establishment Name:  U&I CORP..
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Proprietary Device Name:   SPREADER,GUIDE PIN (SM,LG), TESTER(STRAIGHT, CURVED),PERSUADER,ROCKER,RATCHET HA
Registered Establishment Name:  U&I CORP..
Classification:   TEMPLATE
Generic Device Name:   TEMPLATE
Proprietary Device Name:   ROD TEMPLATE 200MM, ROD TEMPLATE 400MM
Registered Establishment Name:  U&I CORP..
Classification:   GAUGE, DEPTH
Generic Device Name:   DEPTH GAUGE
Proprietary Device Name:   DEPTH GAUGE
Registered Establishment Name:  U&I CORP..
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  HEALING SURGICAL CORP..
Classification:   TEMPLATE
Generic Device Name:   ANATOMICAL MODELS
Proprietary Device Name:   CLEARVIEW(TM) ANATOMICAL MODEL, RAPIDVIEW(TM) ANATOMICAL MODEL
Registered Establishment Name:  MEDICAL MODELING LLC.
Classification:   HOLDER, NEEDLE; ORTHOPEDIC
Generic Device Name:   VARIOUS TYPES OF NEEDLES HOLDERS
Proprietary Device Name:   HOLDER, NEEDLE; ORTHOPEDIC
Registered Establishment Name:  BOWEN SURGICAL, INC..
Classification:   PASSER, WIRE, ORTHOPEDIC
Generic Device Name:   VARIOUS TYPES OF WIRE PASSERS
Proprietary Device Name:   PASSER, WIRE, ORTHOPEDIC
Registered Establishment Name:  BOWEN SURGICAL, INC..
Classification:   BIT, DRILL
Generic Device Name:   VARIOUS SIZES HIGH SPEED DRILLS
Proprietary Device Name:   BIT, DRILL
Registered Establishment Name:  BOWEN SURGICAL, INC..
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   MULTIPLE
Proprietary Device Name:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Registered Establishment Name:  BOWEN SURGICAL, INC..
Classification:   COMPONENT, TRACTION, INVASIVE
Generic Device Name:   OLECRANON SCREW
Proprietary Device Name:   SYSTEM, EXTERNAL FIXATOR (WITH NON-METALLIC INVASIVE COMPONENTS)
Registered Establishment Name:  BOWEN SURGICAL, INC..
Classification:   GONIOMETER, NONPOWERED
Generic Device Name:   VARIOUS TYPES OF GONIOMETERS
Proprietary Device Name:   GONIOMETER, NONPOWERED
Registered Establishment Name:  BOWEN SURGICAL, INC..
Classification:   PASSER
Generic Device Name:   TENDON PASSER
Proprietary Device Name:   PASSER
Registered Establishment Name:  BOWEN SURGICAL, INC..
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   SCISSORS
Proprietary Device Name:   SCISSORS
Registered Establishment Name:  MIR GROUP OF INDUSTRIES.
Classification:   ARTHROSCOPE
Generic Device Name:   ARTHROSCOPE
Proprietary Device Name:   ARTHROSCOPE
Registered Establishment Name:  GLOBAL ENDOSCOPY, INC..

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Last Modified: 29 April 2006
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