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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:   WASHER, BOLT, NUT, NON-SPINAL, METALLIC
Generic Device Name:   WASHER, BOLT, NUT, NON-SPINAL, METALLIC
Proprietary Device Name:   WASHER, BOLT, NUT, NON-SPINAL, METALLIC
Registered Establishment Name:  ZEPF MEDICAL INSTRUMENTS GMBH.
Classification:   PASSER, WIRE, ORTHOPEDIC
Generic Device Name:   PASSER, WIRE, ORTHOPEDIC
Proprietary Device Name:   PASSER, WIRE, ORTHOPEDIC
Registered Establishment Name:  ZEPF MEDICAL INSTRUMENTS GMBH.
Classification:   PROBE
Generic Device Name:   PROBE
Proprietary Device Name:   PROBE
Registered Establishment Name:  ZEPF MEDICAL INSTRUMENTS GMBH.
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   SCISSORS
Proprietary Device Name:   SCISSORS
Registered Establishment Name:  ZEPF MEDICAL INSTRUMENTS GMBH.
Classification:   SCREWDRIVER
Generic Device Name:   SCREWDRIVER
Proprietary Device Name:   SCREWDRIVER
Registered Establishment Name:  ZEPF MEDICAL INSTRUMENTS GMBH.
Classification:   TWISTER, WIRE
Generic Device Name:   TWISTER, WIRE
Proprietary Device Name:   TWISTER, WIRE
Registered Establishment Name:  ZEPF MEDICAL INSTRUMENTS GMBH.
Classification:   WIRE, SURGICAL
Generic Device Name:   WIRE, SURGICAL
Proprietary Device Name:   WIRE, SURGICAL
Registered Establishment Name:  ZEPF MEDICAL INSTRUMENTS GMBH.
Classification:   WRENCH
Generic Device Name:   WRENCH
Proprietary Device Name:   WRENCH
Registered Establishment Name:  ZEPF MEDICAL INSTRUMENTS GMBH.
Classification:   CUTTER, WIRE
Generic Device Name:   CUTTER, WIRE
Proprietary Device Name:   CUTTER, WIRE
Registered Establishment Name:  ZEPF MEDICAL INSTRUMENTS GMBH.
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:  ZEPF MEDICAL INSTRUMENTS GMBH.
Classification:   BIT, DRILL
Generic Device Name:   VARIOUS SIZES OF DRILL BITS
Proprietary Device Name:   STAINLESS STEEL DRILL BIT
Registered Establishment Name:  SURGICAL IMPLANT GENERATION NETWORK (SIGN).
Classification:   REAMER
Generic Device Name:   REAMER
Proprietary Device Name:   HAND REAMER
Registered Establishment Name:  SURGICAL IMPLANT GENERATION NETWORK (SIGN).
Classification:   EXTRACTOR
Generic Device Name:   EXTRACTOR
Proprietary Device Name:   IM NAIL EXTRACTOR
Registered Establishment Name:  SURGICAL IMPLANT GENERATION NETWORK (SIGN).
Classification:   STARTER, BONE SCREW
Generic Device Name:   PUNCH
Proprietary Device Name:   BONE PUNCH
Registered Establishment Name:  SURGICAL IMPLANT GENERATION NETWORK (SIGN).
Classification:   TEMPLATE
Generic Device Name:   JIG
Proprietary Device Name:   PROXIMAL/DISTAL TARGETING TOOL (ASSY.)
Registered Establishment Name:  SURGICAL IMPLANT GENERATION NETWORK (SIGN).
Classification:   PROBE
Generic Device Name:   PROBE
Proprietary Device Name:   SLOT FINDER TOOL
Registered Establishment Name:  SURGICAL IMPLANT GENERATION NETWORK (SIGN).
Classification:   SCREWDRIVER
Generic Device Name:   SCREW DRIVER
Proprietary Device Name:   HEX DRIVER
Registered Establishment Name:  SURGICAL IMPLANT GENERATION NETWORK (SIGN).
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   SHIELD
Proprietary Device Name:   TISSUE PROTECTOR
Registered Establishment Name:  SURGICAL IMPLANT GENERATION NETWORK (SIGN).
Classification:   SCREW, FIXATION, BONE, NON-SPINAL, METALLIC
Generic Device Name:   VARIOUS SIZES OF CORTICAL SCREWS
Proprietary Device Name:   SERIES IV STEP SCREW
Registered Establishment Name:  SURGICAL IMPLANT GENERATION NETWORK (SIGN).
Classification:   AWL
Generic Device Name:   AWL
Proprietary Device Name:   AWL
Registered Establishment Name:  SURGICAL IMPLANT GENERATION NETWORK (SIGN).
Classification:   GAUGE, DEPTH
Generic Device Name:   DEPTH GAUGE
Proprietary Device Name:   DEPTH GAUGE
Registered Establishment Name:  SURGICAL IMPLANT GENERATION NETWORK (SIGN).
Classification:   ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Generic Device Name:   VARIOUS SIZES AND TYPES OF IM NAILS
Proprietary Device Name:   SIGN IM NAIL
Registered Establishment Name:  SURGICAL IMPLANT GENERATION NETWORK (SIGN).
Classification:   PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
Generic Device Name:   VARIOUS TYPES OF KNEE PROSTHESES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SMITH & NEPHEW, INC..
Classification:   PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
Generic Device Name:   PATELLO-FEMORAL KNEE PROSTHESIS
Proprietary Device Name:   PATELLO-FEMORAL KNEE PROSTHESIS
Registered Establishment Name:  SMITH & NEPHEW, INC..
Classification:   PIN, FIXATION, SMOOTH
Generic Device Name:   K-WIRE END PROTECTOR
Proprietary Device Name:   K-FIX
Registered Establishment Name:  AXONE.
Classification:   ACCESSORIES,ARTHROSCOPIC
Generic Device Name:   ARTHROSCOPIC PUMP
Proprietary Device Name:   ARTHROSCOPIC PUMP
Registered Establishment Name:  W.O.M. WORLD OF MEDICINE AG.
Classification:   FILLER, BONE VOID, MEDICATED
Generic Device Name:   SKELITE TM SYNTHETIC RESORBABLE BONE VOID FILLER
Proprietary Device Name:   MILLENIUM'S SKELITETM SYNTHETIC RESORBABLE BONE VOID FILTER
Registered Establishment Name:  MILLENIUM BIOLOGIX, INC..
Classification:   TREPHINE
Generic Device Name:   TREPHINE DRILLS
Proprietary Device Name:   TREPHINE DRILLS
Registered Establishment Name:  SALVIN DENTAL SPECIALTIES, INC..
Classification:   HOLDER, NEEDLE; ORTHOPEDIC
Generic Device Name:   VARIOUS TYPES OF NEEDLE HOLDERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SALVIN DENTAL SPECIALTIES, INC..
Classification:   SCREWDRIVER
Generic Device Name:   VARIOUS TYPES OF DENTAL SCREWDRIVERS AND ACCESSORIES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SALVIN DENTAL SPECIALTIES, INC..
Classification:   CALIPER
Generic Device Name:   VARIOUS TYPES OF CALIPERS AND MEASURING DEVICES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SALVIN DENTAL SPECIALTIES, INC..
Classification:   GONIOMETER, AC-POWERED
Generic Device Name:   ORTELIUS 800
Proprietary Device Name:   ORTELIUS 800
Registered Establishment Name:  ORTHOSCAN LTD..
Classification:   FILLER, BONE VOID, CALCIUM COMPOUND
Generic Device Name:   CALCIUM SULFATE PELLETS
Proprietary Device Name:   MBCP
Registered Establishment Name:  BIOMATLANTE.
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   MANUAL SURGICAL INSTRUMENT FOR PASSING TENDON THROUGH BONE
Proprietary Device Name:   TENDONE
Registered Establishment Name:  ORTHOFIL SARL.
Classification:   BONE CEMENT
Generic Device Name:   BONE CEMENT
Proprietary Device Name:   BONE CEMENT
Registered Establishment Name:  INSTITUTE OF TECHNICAL SCIENCES OF THE ACADEMY.
Classification:   CALIPER
Generic Device Name:   HIP CALIPER
Proprietary Device Name:   HIP CALIPER
Registered Establishment Name:  UPPER CERVICAL STORE, INC..
Classification:   RONGEUR
Generic Device Name:   VARIOUS TYPES OF RONGEURS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ANTYLLOS MEDIZINTECHNIK GMBH.
Classification:   IMPACTOR
Generic Device Name:   VARIOUS TYPES OF IMPACTORS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ANTYLLOS MEDIZINTECHNIK GMBH.
Classification:   INSTRUMENT, COMPRESSION
Generic Device Name:   VARIOUS TYPES OF OSTEOTOMES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ANTYLLOS MEDIZINTECHNIK GMBH.
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   VARIOUS TYPES OF MANUAL SURGICAL INSTRUMENTS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ANTYLLOS MEDIZINTECHNIK GMBH.

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Last Modified: 29 April 2006
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