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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:   ORTHOSIS, SPONDYLOISTHESIS SPINAL FIXATION
Generic Device Name:   MULTIPLE
Proprietary Device Name:   ORTHOSIS, SPONDYLOISTHESIS SPINAL FIXATION
Registered Establishment Name:  INTERPORE CROSS INTL..
Classification:   INSTRUMENT, BENDING OR CONTOURING
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SYNTHES TUTTLINGEN.
Classification:   CUTTER, WIRE
Generic Device Name:   VARIOUS TYPES AND SIZES OF WIRE CUTTERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SYNTHES TUTTLINGEN.
Classification:   IMPACTOR
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SYNTHES TUTTLINGEN.
Classification:   WRENCH
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SYNTHES TUTTLINGEN.
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SYNTHES TUTTLINGEN.
Classification:   RONGEUR
Generic Device Name:   VARIOUS
Proprietary Device Name:   RONGEUR
Registered Establishment Name:  SYNTHES TUTTLINGEN.
Classification:   TEMPLATE
Generic Device Name:   TEMPLATE/SIZER
Proprietary Device Name:   VARIOUS
Registered Establishment Name:  SYNTHES TUTTLINGEN.
Classification:   CRIMPER, PIN
Generic Device Name:   CRIMPER
Proprietary Device Name:   CRIMPER
Registered Establishment Name:  SYNTHES TUTTLINGEN.
Classification:   TWISTER, WIRE
Generic Device Name:   WIRE TWISTER
Proprietary Device Name:   WIRE TWISTER
Registered Establishment Name:  SYNTHES TUTTLINGEN.
Classification:   REAMER
Generic Device Name:   VARIOUS TYPES AND SIZES OF REAMERS
Proprietary Device Name:   REAMER (MULTIPLE BRANDS)
Registered Establishment Name:  SYNTHES TUTTLINGEN.
Classification:   SCREWDRIVER
Generic Device Name:   VARIOUS TYPES AND SIZES OF SCREWDRIVERS AND ACCESSORIES
Proprietary Device Name:   SCREWDRIVER (MULTIPLE BRANDS)
Registered Establishment Name:  SYNTHES TUTTLINGEN.
Classification:   CALIPER
Generic Device Name:   VARIOUS TYPES AND SIZES OF CALIPERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SYNTHES TUTTLINGEN.
Classification:   GAUGE, DEPTH
Generic Device Name:   VARIUOS TYPES AND SIZES OF DEPTH GAUGES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SYNTHES TUTTLINGEN.
Classification:   AWL
Generic Device Name:   VARIOUS TYPES AND SIZES OF AWLS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SYNTHES TUTTLINGEN.
Classification:   INSTRUMENT, COMPRESSION
Generic Device Name:   VARIOUS TYPES AND SIZES OF COMPRESSION INSTRUMENTS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SYNTHES TUTTLINGEN.
Classification:   WRENCH
Generic Device Name:   WRENCH
Proprietary Device Name:   WRENCH
Registered Establishment Name:  FEITER'S INC.
Classification:   BONE MILL
Generic Device Name:   BONE CRUSHER, ALL TYPES
Proprietary Device Name:   BONE CRUSHER
Registered Establishment Name:  H & H CO..
Classification:   PIN, FIXATION, SMOOTH, METALLIC
Generic Device Name:   PINS & WIRES
Proprietary Device Name:   MEDICAL PRODUCTS RESOURCE
Registered Establishment Name:  IMPLANT RESOURCE, INC..
Classification:   CALIPER
Generic Device Name:   CALIPER
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SMT SCHILLING METALLTECHNIK GMBH.
Classification:   INSTRUMENT, BENDING OR CONTOURING
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SMT SCHILLING METALLTECHNIK GMBH.
Classification:   SCREWDRIVER
Generic Device Name:   SCREWDRIVER
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SMT SCHILLING METALLTECHNIK GMBH.
Classification:   PIN, FIXATION, SMOOTH
Generic Device Name:   K-WIRE OR STEINMANN PIN
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  AMERICAN MEDICAL SPECIALTIES, INC..
Classification:   FILE
Generic Device Name:   HARD SKIN REMOVER
Proprietary Device Name:   HARD SKIN REMOVER
Registered Establishment Name:  JANFORD DEVELOPMENT LTD..
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   SCISSORS
Proprietary Device Name:   SCISSORS
Registered Establishment Name:  NASIFI CORP..
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   VARIOUS SIZES OF STERILE AND NON STERILE SCISSORS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  KELLY DENT SUPPLIES.
Classification:   BONE CEMENT
Generic Device Name:   STERILE BONE CEMENT
Proprietary Device Name:   SUBITON SURGICAL
Registered Establishment Name:  PROTHOPLAST S.A..
Classification:   SCREW, FIXATION, BONE
Generic Device Name:   VARIOUS SIZES OF STERILE ABSORBABLE THREADED FIXATION PINS
Proprietary Device Name:   BIOFIX PGA SCREWS
Registered Establishment Name:  BIOSCIENCE, INC..
Classification:   ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Generic Device Name:   VARIOUS SIZES OF STERILE ABSORBABLE FIXATION PINS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  BIOSCIENCE, INC..
Classification:   PIN, FIXATION, SMOOTH
Generic Device Name:   VARIOUS SIZES AND TYPES OF STERILE PACKAGED, ABSORBABLE BONE FIXATION PINS
Proprietary Device Name:   BIOFIX
Registered Establishment Name:  BIOSCIENCE, INC..
Classification:   PIN, FIXATION, THREADED
Generic Device Name:   VARIOUS SIZES AND TYPES OF STERILE PACKAGED, ABSORBABLE BONE FIX. THREADED RODS.
Proprietary Device Name:   BIOFIX
Registered Establishment Name:  BIOSCIENCE, INC..
Classification:   FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  BIOSCIENCE, INC..
Classification:   INSTRUMENT, CAST APPLICATION/REMOVAL, MANUAL
Generic Device Name:   INSTRUMENT, CAST APPLICATION/REMOVAL, MANUAL
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  RICHARD GUT CHIR. INSTRUMENTE GMBH.
Classification:   SCREW, FIXATION, BONE
Generic Device Name:   BONE OR INTERFERENCE SCREW, STERILE AND NONSTERILE
Proprietary Device Name:   ENDO SURGICAL CONCEPTS INTERFERENCE SCREW SYSTEM
Registered Establishment Name:  ENDO SURGICAL CONCEPTS, INC..
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Proprietary Device Name:   ENDO SURGICAL CONCEPTS GUIDE SYSTEM
Registered Establishment Name:  ENDO SURGICAL CONCEPTS, INC..
Classification:   BONE CEMENT
Generic Device Name:   NONE
Proprietary Device Name:   BONELOC BONE CEMENT
Registered Establishment Name:  POLYMERS RECONSTRUCTIVE A/S.
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   SCISSORS, ORTHOPEDIC
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SOS SURGICAL CO.,.
Classification:   REAMER
Generic Device Name:   REAMER
Proprietary Device Name:   ALIQUOT MICRO REAMER
Registered Establishment Name:  ORTHOVITA, INC..
Classification:   DISPENSER, CEMENT
Generic Device Name:   CEMENT DISPENSER
Proprietary Device Name:   ALIQUOT CEMENT DISPENSER
Registered Establishment Name:  ORTHOVITA, INC..
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   FUNNEL
Proprietary Device Name:   IMBIBE VIAL FUNNEL
Registered Establishment Name:  ORTHOVITA, INC..

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Last Modified: 29 April 2006
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