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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:   AWL
Generic Device Name:   VARIOUS
Proprietary Device Name:   AWL
Registered Establishment Name:  SYNTHES BETTLACH GMBH.
Classification:   WRENCH
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SYNTHES BETTLACH GMBH.
Classification:   APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SYNTHES BETTLACH GMBH.
Classification:   APPLIANCE, FIXATION, SPINAL INTERLAMINAL
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SYNTHES BETTLACH GMBH.
Classification:   TWISTER, WIRE
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SYNTHES BETTLACH GMBH.
Classification:   INSTRUMENT, BENDING OR CONTOURING
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SYNTHES BETTLACH GMBH.
Classification:   WIRE, SURGICAL
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SYNTHES BETTLACH GMBH.
Classification:   FIXATION ACCESSORY
Generic Device Name:   VARIOUS TYPES AND SIZES OF FIXATION ACCESSORIES
Proprietary Device Name:   LIGAMENT FIXATION PLATE
Registered Establishment Name:  SYNTHES BETTLACH GMBH.
Classification:   PASSER, WIRE, ORTHOPEDIC
Generic Device Name:   VARIOUS TYPES AND SIZES OF PASSERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SYNTHES BETTLACH GMBH.
Classification:   STAPLE DRIVER
Generic Device Name:   VARIOUS TYPES AND SIZES OF DRIVER STAPLES
Proprietary Device Name:   STAPLE INSERTER
Registered Establishment Name:  SYNTHES BETTLACH GMBH.
Classification:   PUSHER, SOCKET
Generic Device Name:   VARIOUS TYPES AND SIZES OF PUSHERS
Proprietary Device Name:   SOCKET PUSHER
Registered Establishment Name:  SYNTHES BETTLACH GMBH.
Classification:   CRIMPER, PIN
Generic Device Name:   VARIOUS TYPES AND SIZES OF PIN CRIMPERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SYNTHES BETTLACH GMBH.
Classification:   TREPHINE
Generic Device Name:   VARIOUS TYPES AND SIZES OF TREPHINES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SYNTHES BETTLACH GMBH.
Classification:   PASSER
Generic Device Name:   VARIOUS TYPES SIZES OF ORTHOPAEDIC,WIRE,PASSERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SYNTHES BETTLACH GMBH.
Classification:   BURR, ORTHOPEDIC
Generic Device Name:   VARIOUS TYPES AND SIZES OF BURRS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SYNTHES BETTLACH GMBH.
Classification:   GONIOMETER, NONPOWERED
Generic Device Name:   VARIOUS TYPES AND SIZES OF ORTHOPAEDIC GONIOMETERS
Proprietary Device Name:   GONIOMETER
Registered Establishment Name:  SYNTHES BETTLACH GMBH.
Classification:   APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, SINGLE COMPONENT
Generic Device Name:   VARIOUS TYPES AND SIZES OF STERILE AND NON-STERILE,SINGLE COMPONENT,NAIL/BLADE/P
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SYNTHES BETTLACH GMBH.
Classification:   STAPLE, FIXATION, BONE
Generic Device Name:   VARIOUS TYPES AND SIZES OF STERILE AND NON-STERILE BONE STAPLES
Proprietary Device Name:   BONE STAPLE
Registered Establishment Name:  SYNTHES BETTLACH GMBH.
Classification:   IMPLANT, FIXATION DEVICE, CONDYLAR PLATE
Generic Device Name:   VARIOUS TYPES AND SIZES OF CONDYLAR PLATE,FIXATION DEVICE,IMPLANTS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SYNTHES BETTLACH GMBH.
Classification:   CUTTER, WIRE
Generic Device Name:   VARIOUS TYPES AND SIZES OF WIRE CUTTERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SYNTHES BETTLACH GMBH.
Classification:   ACCESSORIES, FIXATION, SPINAL INTERLAMINAL
Generic Device Name:   VARIOUS SIZES AND TYPES OF INTERLAMINAL, SPINAL, FIXATION ACCESSORIES.
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SYNTHES BETTLACH GMBH.
Classification:   COMPONENT, TRACTION, INVASIVE
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SYNTHES BETTLACH GMBH.
Classification:   GAUGE, DEPTH
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SYNTHES BETTLACH GMBH.
Classification:   NAIL, FIXATION, BONE
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SYNTHES BETTLACH GMBH.
Classification:   PIN, FIXATION, THREADED
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SYNTHES BETTLACH GMBH.
Classification:   SCREWDRIVER
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SYNTHES BETTLACH GMBH.
Classification:   WASHER, BOLT NUT
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SYNTHES BETTLACH GMBH.
Classification:   REAMER
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SYNTHES BETTLACH GMBH.
Classification:   COUNTERSINK
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SYNTHES BETTLACH GMBH.
Classification:   APPARATUS, TRACTION, NON-POWERED
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SYNTHES BETTLACH GMBH.
Classification:   PIN, FIXATION, SMOOTH
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SYNTHES BETTLACH GMBH.
Classification:   IMPACTOR
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SYNTHES BETTLACH GMBH.
Classification:   SCREW, FIXATION, BONE
Generic Device Name:   VARIOUS
Proprietary Device Name:   SCREW
Registered Establishment Name:  SYNTHES BETTLACH GMBH.
Classification:   STARTER, BONE SCREW
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SYNTHES BETTLACH GMBH.
Classification:   ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SYNTHES BETTLACH GMBH.
Classification:   BIT, DRILL
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SYNTHES BETTLACH GMBH.
Classification:   INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SYNTHES BETTLACH GMBH.
Classification:   PLATE, FIXATION, BONE
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SYNTHES BETTLACH GMBH.
Classification:   FILLER, BONE VOID, CALCIUM COMPOUND
Generic Device Name:   VARIOUS TYPES AND SIZES OF BONE VOID FILLERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SYNTHES BETTLACH GMBH.
Classification:   APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT, METAL COMPOSITE
Generic Device Name:   VARIOUS TYPE AND SIZES OF NAIL/BLADE/PLATE COMBINATION FIXATION APPLIANCES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SYNTHES BETTLACH GMBH.

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Last Modified: 29 April 2006
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