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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:   REAMER
Generic Device Name:   SURGICAL OR PROSTHETIC INSTRUMENT
Proprietary Device Name:   REAMER
Registered Establishment Name:  NOBEL BIOCARE (PRODUCTION) AB.
Classification:   IMPACTOR
Generic Device Name:   SURGICAL INSTRUMENT
Proprietary Device Name:   IMPACTOR
Registered Establishment Name:  NOBEL BIOCARE (PRODUCTION) AB.
Classification:   WRENCH
Generic Device Name:   SURGICAL OR PROSTHETIC INSTRUMENT
Proprietary Device Name:   WRENCH
Registered Establishment Name:  NOBEL BIOCARE (PRODUCTION) AB.
Classification:   SCREWDRIVER
Generic Device Name:   PROSTHETIC INSTRUMENT
Proprietary Device Name:   SCREWDRIVER
Registered Establishment Name:  NOBEL BIOCARE (PRODUCTION) AB.
Classification:   EXTRACTOR
Generic Device Name:   SURGICAL INSTRUMENT
Proprietary Device Name:   EXTRACTOR
Registered Establishment Name:  NOBEL BIOCARE (PRODUCTION) AB.
Classification:   REAMER
Generic Device Name:   SURGICAL OR PROSTHETIC INSTRUMENT
Proprietary Device Name:   REAMER
Registered Establishment Name:  NOBEL BIOCARE AB.
Classification:   IMPACTOR
Generic Device Name:   SURGICAL INSTRUMENT
Proprietary Device Name:   IMPACTOR
Registered Establishment Name:  NOBEL BIOCARE AB.
Classification:   WRENCH
Generic Device Name:   SURGICAL OR PROSTHETIC INSTRUMENT
Proprietary Device Name:   WRENCH
Registered Establishment Name:  NOBEL BIOCARE AB.
Classification:   SCREWDRIVER
Generic Device Name:   PROSTHETIC INSTRUMENT
Proprietary Device Name:   SCREWDRIVER
Registered Establishment Name:  NOBEL BIOCARE AB.
Classification:   EXTRACTOR
Generic Device Name:   SURGICAL INSTRUMENT
Proprietary Device Name:   EXTRACTOR
Registered Establishment Name:  NOBEL BIOCARE AB.
Classification:   DYNAMOMETER, NONPOWERED
Generic Device Name:   ALGOMETER
Proprietary Device Name:   ALGOMETER
Registered Establishment Name:  SOMEDIC SALES AB.
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  BIOMET CEMENTING TECHNOLOGIES AB.
Classification:   APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, SINGLE COMPONENT
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SYNTHES GMBH.
Classification:   APPLIANCE, FIXATION, SPINAL INTERLAMINAL
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SYNTHES GMBH.
Classification:   WIRE, SURGICAL
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SYNTHES GMBH.
Classification:   INSTRUMENT, BENDING OR CONTOURING
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SYNTHES GMBH.
Classification:   GAUGE, DEPTH
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SYNTHES GMBH.
Classification:   APPARATUS, TRACTION, NON-POWERED
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SYNTHES GMBH.
Classification:   PLATE, FIXATION, BONE
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SYNTHES GMBH.
Classification:   PUSHER, SOCKET
Generic Device Name:   VARIOUS TYPES AND SIZES OF PUSHERS
Proprietary Device Name:   SOCKET PUSHER
Registered Establishment Name:  SYNTHES GMBH.
Classification:   BENDER
Generic Device Name:   VARIOUS TYPES AND SIZES OF BENDERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SYNTHES GMBH.
Classification:   INSTRUMENT, COMPRESSION
Generic Device Name:   VARIOUS TYPES AND SIZES OF COMPRESSION INSTRUMENTS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SYNTHES GMBH.
Classification:   CRIMPER, PIN
Generic Device Name:   VARIOUS TYPES AND SIZES OF PIN CRIMPERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SYNTHES GMBH.
Classification:   SCREW, FIXATION, BONE
Generic Device Name:   VARIOUS
Proprietary Device Name:   SCREW
Registered Establishment Name:  SYNTHES GMBH.
Classification:   IMPACTOR
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SYNTHES GMBH.
Classification:   TEMPLATE
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SYNTHES GMBH.
Classification:   TAP, BONE
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SYNTHES GMBH.
Classification:   WRENCH
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SYNTHES GMBH.
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SYNTHES GMBH.
Classification:   COMPONENT, TRACTION, INVASIVE
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SYNTHES GMBH.
Classification:   INSTRUMENT, SURGICAL, ORTHOPEDIC, PNEUMATIC POWERED & ACCESSORY/ATTACHMENT
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SYNTHES GMBH.
Classification:   SCREWDRIVER
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SYNTHES GMBH.
Classification:   PIN, FIXATION, SMOOTH
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SYNTHES GMBH.
Classification:   REAMER
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SYNTHES GMBH.
Classification:   CERCLAGE, FIXATION
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SYNTHES GMBH.
Classification:   IMPLANT, FIXATION DEVICE, CONDYLAR PLATE
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SYNTHES GMBH.
Classification:   WASHER, BOLT NUT
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SYNTHES GMBH.
Classification:   PIN, FIXATION, THREADED
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SYNTHES GMBH.
Classification:   APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SYNTHES GMBH.
Classification:   FIXATION ACCESSORY
Generic Device Name:   VARIOUS
Proprietary Device Name:   LIGAMENT FIXATION PLATE
Registered Establishment Name:  SYNTHES GMBH.

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Last Modified: 29 April 2006
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