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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:   SCREWDRIVER
Generic Device Name:   SCREWDRIVER
Proprietary Device Name:   HEX HEAD SCREWDRIVER 10225, 10005, 10025
Registered Establishment Name:  INSTRATEK, INC..
Classification:   REAMER
Generic Device Name:   REAMER
Proprietary Device Name:   REAMER
Registered Establishment Name:  FORESTADENT BERNHARD FORSTER GMBH.
Classification:   CUTTER, WIRE
Generic Device Name:   VARIOUS TYPES OF PIN CUTTERS
Proprietary Device Name:   CUTTER
Registered Establishment Name:  HANS DIETER ZEPF FABRIK, CHIRURGISCHER INSTRUMENTE.
Classification:   INSTRUMENT, CAST REMOVAL, AC-POWERED
Generic Device Name:   INSTRUMENT, CAST REMOVAL, AC-POWERED
Proprietary Device Name:   INSTRUMENT, CAST REMOVAL, AC-POWERED
Registered Establishment Name:  CASCADE ORTHOPEDIC SUPPLY, INC..
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   VARIOUS TYPES AND SIZES OF SCISSORS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  HOBRI INTL..
Classification:   EXTRACTOR
Generic Device Name:   VARIOUS
Proprietary Device Name:   COMEDONE, UNA
Registered Establishment Name:  AF INSTRUMENTE.
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   VARIOUS TYPES OF SCISSORS, ORTHOPEDIC
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  HGR INSTRUMENTE GMBH.
Classification:   INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
Generic Device Name:   PATELLAR TENDON GRAFT HARVESTING INSTRUMENT SET (ORTHOPEDIC INSTRUMENTS)
Proprietary Device Name:   'THE GRAFTOLOGER' GRAFT HARVESTING INSTRUMENT SET
Registered Establishment Name:  XIROS PLC.
Classification:   STAPLE DRIVER
Generic Device Name:   STAPLE IMPACTOR/PUNCH
Proprietary Device Name:   NEOLIGAMENTS STAPLE OR PUNCH IMPACTOR
Registered Establishment Name:  XIROS PLC.
Classification:   EXTRACTOR
Generic Device Name:   ORTHOPEDIC STAPLE EXTRACTOR
Proprietary Device Name:   NEOLIGAMENTS EXTRACTOR
Registered Establishment Name:  XIROS PLC.
Classification:   REAMER
Generic Device Name:   REAMER
Proprietary Device Name:   NEOLIGAMENTS REAMER
Registered Establishment Name:  XIROS PLC.
Classification:   STAPLE, FIXATION, BONE
Generic Device Name:   IMPLANTABLE STAPLE WITH SOFT TISSUE BUCKLE RETAINER
Proprietary Device Name:   FASTLOK FIXATION DEVICE
Registered Establishment Name:  XIROS PLC.
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   SCISSORS
Proprietary Device Name:   EKAL SURGICAL WORKS
Registered Establishment Name:  EKAL SURGICAL WORKS.
Classification:   PROBE
Generic Device Name:   PROBES
Proprietary Device Name:   EKAL SURGICAL WORKS
Registered Establishment Name:  EKAL SURGICAL WORKS.
Classification:   DYNAMOMETER, NONPOWERED
Generic Device Name:   DMG250, EG250-M MUSCLE STRENGTH DYNAMOMETER
Proprietary Device Name:   DYNAMOMETER
Registered Establishment Name:  AMETEK.
Classification:   DYNAMOMETER, AC-POWERED
Generic Device Name:   ISOMETRIC STRENGTH DYNAMOMETER
Proprietary Device Name:   DYNAMOMETER
Registered Establishment Name:  AMETEK.
Classification:   WASHER, BOLT NUT
Generic Device Name:   HEX BUTTON
Proprietary Device Name:   PIONEER LABORATORIES HEX BUTTON
Registered Establishment Name:  PIONEER SURGICAL TECHNOLOGY.
Classification:   IMPLANT, FIXATION DEVICE, SPINAL
Generic Device Name:   LUQUE SPINAL ROD
Proprietary Device Name:   SONGER TITANIUM SPINE L-ROD
Registered Establishment Name:  PIONEER SURGICAL TECHNOLOGY.
Classification:   ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  PIONEER SURGICAL TECHNOLOGY.
Classification:   CERCLAGE, FIXATION
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  PIONEER SURGICAL TECHNOLOGY.
Classification:   SCREW, FIXATION, BONE
Generic Device Name:   STAYFUSE GT-IP
Proprietary Device Name:   STAYFUSE GT-IP
Registered Establishment Name:  PIONEER SURGICAL TECHNOLOGY.
Classification:   ORTHOSIS, SPINAL PEDICLE FIXATION
Generic Device Name:   POSTERIOR CABLE SCREW
Proprietary Device Name:   POSTERIOR CABLE SCREW
Registered Establishment Name:  PIONEER SURGICAL TECHNOLOGY.
Classification:   TEMPLATE
Generic Device Name:   PATTERN OR GUIDE FOR ORTHOPEDIC IMPLANTS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  PIONEER SURGICAL TECHNOLOGY.
Classification:   AWL
Generic Device Name:   AWL
Proprietary Device Name:   AWL
Registered Establishment Name:  PIONEER SURGICAL TECHNOLOGY.
Classification:   SCREWDRIVER
Generic Device Name:   SCREWDRIVER
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  PIONEER SURGICAL TECHNOLOGY.
Classification:   TAP, BONE
Generic Device Name:   TAP
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  PIONEER SURGICAL TECHNOLOGY.
Classification:   BENDER
Generic Device Name:   IN-SITU BENDER, ROD BENDER, LEFT/RIGHT BENDER
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  PIONEER SURGICAL TECHNOLOGY.
Classification:   DRIVER, PROSTHESIS
Generic Device Name:   INSERTER, PERSUADER, ROCKER, ETC.
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  PIONEER SURGICAL TECHNOLOGY.
Classification:   WRENCH
Generic Device Name:   WRENCH, LOCKER
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  PIONEER SURGICAL TECHNOLOGY.
Classification:   INSTRUMENT, COMPRESSION
Generic Device Name:   COMPRESSOR
Proprietary Device Name:   COMPRESSOR
Registered Establishment Name:  PIONEER SURGICAL TECHNOLOGY.
Classification:   ARTHROSCOPE
Generic Device Name:   ARTHROSCOPE AND ACCESSORIES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  WOODBINE OPTICAL CORP..
Classification:   ORTHOSIS, SPINAL INTERVERTEBRAL FUSION
Generic Device Name:   DEWALL POSTURE PROTECTOR L0430
Proprietary Device Name:   DEWALL POSTURE PROTECTOR L0430
Registered Establishment Name:  DEWALL ENT., INC..
Classification:   HOLDER, NEEDLE; ORTHOPEDIC
Generic Device Name:   NEEDLE HOLDER, ORTHOPEDIC
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  THE STRONG HAND.
Classification:   WASHER, BOLT NUT
Generic Device Name:   GREEN NYLON WASHER
Proprietary Device Name:   GREEN NYLON WASHER
Registered Establishment Name:  PLAXTRON INDUSTRIAL (M) SDN. BHD..
Classification:   WRENCH
Generic Device Name:   WRENCH
Proprietary Device Name:   SMALL CYLINDER WRENCH PLASTIC
Registered Establishment Name:  PLAXTRON INDUSTRIAL (M) SDN. BHD..
Classification:   PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNCEMENTED
Generic Device Name:   CERAMIC TRANSCEND HIP ARTICULATION SYSTEM
Proprietary Device Name:   CERAMIC TRANSCEND HIP ARTICULATION SYSTEM
Registered Establishment Name:  CERAMTEC AG.
Classification:   HOLDER, NEEDLE; ORTHOPEDIC
Generic Device Name:   HOLDER
Proprietary Device Name:   JAVEED ASGHAIR
Registered Establishment Name:  NAB-TECH INSTRUMENTS.
Classification:   HOLDER, NEEDLE; ORTHOPEDIC
Generic Device Name:   NEEDLE HOLDER, ORTHOPEDIC
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  MARYAM TRADING.
Classification:   PROBE
Generic Device Name:   PROBE
Proprietary Device Name:   PROBE
Registered Establishment Name:  MARYAM TRADING.
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   SCISSORS
Proprietary Device Name:   SCISSORS
Registered Establishment Name:  MARYAM TRADING.

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Last Modified: 29 April 2006
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