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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:   CRIMPER, PIN
Generic Device Name:   VARIOUS TENSION CRIMPER
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING.
Classification:   REAMER
Generic Device Name:   MULTIPLE (ORTHOPEDIC REAMERS)
Proprietary Device Name:   MULTIPLE (ORTHOPEDIC REAMERS)
Registered Establishment Name:  MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING.
Classification:   BIT, DRILL
Generic Device Name:   VARIOUS TWIST, BIT DRILLS
Proprietary Device Name:   MULTIPLE TWIST, BIT DRILLS
Registered Establishment Name:  MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING.
Classification:   RONGEUR
Generic Device Name:   VARIOUS (RONGEURS)
Proprietary Device Name:   MULTIPLE (RONGEURS)
Registered Establishment Name:  MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING.
Classification:   EXTRACTOR
Generic Device Name:   MULTIPLE (DRIVER-EXTRACTORS)
Proprietary Device Name:   MULTIPLE (DRIVER-EXTRACTORS)
Registered Establishment Name:  MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING.
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   MULTIPLE (SCISSORS)
Proprietary Device Name:   MULTIPLE (SCISSORS)
Registered Establishment Name:  MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING.
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING.
Classification:   COUNTERSINK
Generic Device Name:   COUNTERSINK
Proprietary Device Name:   COUNTERSINK
Registered Establishment Name:  MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING.
Classification:   CUTTER, WIRE
Generic Device Name:   VARIOUS TYPES OF ORTHOPEDIC WIRE CUTTERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING.
Classification:   INSTRUMENT, COMPRESSION
Generic Device Name:   PLATE AND SCREW COMPRESSION DEVICES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING.
Classification:   WRENCH
Generic Device Name:   VARIOUS TYPES OF ORTHOPEDIC WRENCHES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING.
Classification:   SCREWDRIVER
Generic Device Name:   SCREWDRIVER, ORTHOPEDIC
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING.
Classification:   TAMP
Generic Device Name:   MULTPLE TAMPS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING.
Classification:   ACCESSORIES,ARTHROSCOPIC
Generic Device Name:   ARTHROSCOPE
Proprietary Device Name:   ARTHROSCOPE
Registered Establishment Name:  MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING.
Classification:   INSTRUMENT, BENDING OR CONTOURING
Generic Device Name:   VARIOUS ROD BENDERS
Proprietary Device Name:   ROD BENDER
Registered Establishment Name:  MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING.
Classification:   GAUGE, DEPTH
Generic Device Name:   MULTIPLE (DEPTH GAUGES)
Proprietary Device Name:   MULTIPLE (DEPTH GAUGES)
Registered Establishment Name:  MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING.
Classification:   APPARATUS, TRACTION, NON-POWERED
Generic Device Name:   TRACTION DEVICE
Proprietary Device Name:   WRIST RELIEVER
Registered Establishment Name:  BENEFICIAL PRODUCTS, INC..
Classification:   FILLER, BONE VOID, CALCIUM COMPOUND
Generic Device Name:   RESORBABLE SYNTHETIC BONE VOID FILLER / BONE GRAFT SUBSTITUTE
Proprietary Device Name:   BGRAN "MULTIPLE"
Registered Establishment Name:  ORTHOS (UK) LIMITED.
Classification:   BELT, PELVIC, TRACTION
Generic Device Name:   PELVIC TRACTION
Proprietary Device Name:   GPC
Registered Establishment Name:  GLOBAL PRODUCTS CORP..
Classification:   APPARATUS, TRACTION, NON-POWERED
Generic Device Name:   OVERDOOR TRACTION AND PULLEY SET AND PELVIC TRACTION
Proprietary Device Name:   NONE
Registered Establishment Name:  STAR MEDICAL SYSTEMS.
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   MANUAL ORTHOPEDIC SURGICAL INSTRUMENTS (ORTHOPEDIC SCISSORS)
Proprietary Device Name:   LIFECARE SURGICAL INSTRUMENTS (MULTIPLE)
Registered Establishment Name:  LIFECARE SURGICAL INSTRUMENTS.
Classification:   PROTRACTOR
Generic Device Name:   MANUAL ORTHOPEDIC SURGICAL INSTRUMENTS (PROTRACTOR)
Proprietary Device Name:   LIFECARE SURGICAL INSTRUMENTS (MULTIPLE)
Registered Establishment Name:  LIFECARE SURGICAL INSTRUMENTS.
Classification:   GAUGE, DEPTH
Generic Device Name:   MANUAL ORTHOPEDIC SURGICAL INSTRUMENTS (DEPTH GAUGE)
Proprietary Device Name:   LIFECARE SURGICAL INSTRUMENTS (MULTIPLE)
Registered Establishment Name:  LIFECARE SURGICAL INSTRUMENTS.
Classification:   REAMER
Generic Device Name:   MANUAL ORTHOPEDIC SURGICAL INSTRUMENTS (REAMER)
Proprietary Device Name:   LIFECARE SURGICAL INSTRUMENTS (MULTIPLE)
Registered Establishment Name:  LIFECARE SURGICAL INSTRUMENTS.
Classification:   FILE
Generic Device Name:   MANUAL ORTHOPEDIC SURGICAL INSTRUMENTS (FILE)
Proprietary Device Name:   LIFECARE SURGICAL INSTRUMENTS (MULTIPLE)
Registered Establishment Name:  LIFECARE SURGICAL INSTRUMENTS.
Classification:   KNIFE, ORTHOPEDIC
Generic Device Name:   MANUAL ORTHOPEDIC SURGICAL INSTRUMENTS (ORTHOPEDIC KNIFE)
Proprietary Device Name:   LIFECARE SURGICAL INSTRUMENTS (MULTIPLE)
Registered Establishment Name:  LIFECARE SURGICAL INSTRUMENTS.
Classification:   BURR, ORTHOPEDIC
Generic Device Name:   MANUAL ORTHOPEDIC SURGICAL INSTRUMENTS (BURR)
Proprietary Device Name:   LIFECARE SURGICAL INSTRUMENTS (MULTIPLE)
Registered Establishment Name:  LIFECARE SURGICAL INSTRUMENTS.
Classification:   BIT, DRILL
Generic Device Name:   MANUAL ORTHOPEDIC SURGICAL INSTRUMENTS (DRILL BIT)
Proprietary Device Name:   LIFECARE SURGICAL INSTRUMENTS (MULTIPLE)
Registered Establishment Name:  LIFECARE SURGICAL INSTRUMENTS.
Classification:   RONGEUR
Generic Device Name:   MANUAL ORTHOPEDIC SURGICAL INSTRUMENTS (RONGEUR)
Proprietary Device Name:   LIFECARE SURGICAL INSTRUMENTS (MULTIPLE)
Registered Establishment Name:  LIFECARE SURGICAL INSTRUMENTS.
Classification:   EXTRACTOR
Generic Device Name:   MANUAL ORTHOPEDIC SURGICAL INSTRUMENTS (EXTRACTOR)
Proprietary Device Name:   LIFECARE SURGICAL INSTRUMENTS (MULTIPLE)
Registered Establishment Name:  LIFECARE SURGICAL INSTRUMENTS.
Classification:   AWL
Generic Device Name:   MANUAL ORTHOPEDIC SURGICAL INSTRUMENTS (AWL)
Proprietary Device Name:   LIFECARE SURGICAL INSTRUMENTS (MULTIPLE)
Registered Establishment Name:  LIFECARE SURGICAL INSTRUMENTS.
Classification:   INSTRUMENT, COMPRESSION
Generic Device Name:   MANUAL ORTHOPEDIC SURGICAL INSTRUMENTS (COMPRESSION INSTRUMENT)
Proprietary Device Name:   LIFECARE SURGICAL INSTRUMENTS (MULTIPLE)
Registered Establishment Name:  LIFECARE SURGICAL INSTRUMENTS.
Classification:   PUNCH, FEMORAL NECK
Generic Device Name:   MANUAL ORTHOPEDIC SURGICAL INSTRUMENTS (FEMORAL NECK PUNCH)
Proprietary Device Name:   LIFECARE SURGICAL INSTRUMENTS (MULTIPLE)
Registered Establishment Name:  LIFECARE SURGICAL INSTRUMENTS.
Classification:   SET, HOLLOW MILL
Generic Device Name:   MANUAL ORTHOPEDIC SURGICAL INSTRUMENST (HOLLOW MILL SET)
Proprietary Device Name:   LIFECARE SURGICAL INSTRUMENTS (MULTIPLE)
Registered Establishment Name:  LIFECARE SURGICAL INSTRUMENTS.
Classification:   PROBE
Generic Device Name:   MANUAL ORTHOPEDIC SURGICAL INSTRUMENTS (PROBE)
Proprietary Device Name:   LIFECARE SURGICAL INSTRUMENTS (MULTIPLE)
Registered Establishment Name:  LIFECARE SURGICAL INSTRUMENTS.
Classification:   WRENCH
Generic Device Name:   MANUAL ORTHOPEDIC SURGICAL INSTRUMENTS (WRENCH)
Proprietary Device Name:   LIFECARE SURGICAL INSTRUMENTS (MULTIPLE)
Registered Establishment Name:  LIFECARE SURGICAL INSTRUMENTS.
Classification:   TWISTER, WIRE
Generic Device Name:   MANUAL ORTHOPEDIC SURGICAL INSTRUMENTS (WIRE TWISTER)
Proprietary Device Name:   LIFECARE SURGICAL INSTRUMENTS (MULTIPLE)
Registered Establishment Name:  LIFECARE SURGICAL INSTRUMENTS.
Classification:   FORK
Generic Device Name:   MANUAL ORTHOPEDIC SURGICAL INSTRUMENTS (FORK)
Proprietary Device Name:   LIFECARE SURGICAL INSTRUMENTS (MULTIPLE)
Registered Establishment Name:  LIFECARE SURGICAL INSTRUMENTS.
Classification:   INSTRUMENT, BENDING OR CONTOURING
Generic Device Name:   MANUAL ORTHOPEDIC SURGICAL INSTRUMENTS (BENDING OR CONTOURING INSTRUMENT)
Proprietary Device Name:   LIFECARE SURGICAL INSTRUMENTS (MULTIPLE)
Registered Establishment Name:  LIFECARE SURGICAL INSTRUMENTS.
Classification:   SCREWDRIVER
Generic Device Name:   MANUAL ORTHOPEDIC SURGICAL INSTRUMENTS (SCREWDRIVER)
Proprietary Device Name:   LIFECARE SURGICAL INSTRUMENTS (MULTIPLE)
Registered Establishment Name:  LIFECARE SURGICAL INSTRUMENTS.

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Last Modified: 29 April 2006
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