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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:   PROSTHESIS, HIP, SEMI-CONSTRAINED (METAL UNCEMENTED ACETABULAR COMPONENT)
Generic Device Name:   VARIOUS TYPES OF METAL UNCEMENTED ACETABULAR COMP. SEMI-CONSTRAINED HIP PROSTHES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY BRIDGEWATER.
Classification:   PIN, FIXATION, SMOOTH
Generic Device Name:   VARIOUS TYPES OF SMOOTH FIXATION PINS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY BRIDGEWATER.
Classification:   SCREW, FIXATION, BONE
Generic Device Name:   VARIOUS TYPES OF FIXATION BONE SCREWS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY BRIDGEWATER.
Classification:   PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
Generic Device Name:   VARIOUS TYPES OF CEMENTED METAL FEMORAL COMPONENT HIP PROSTHESES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY BRIDGEWATER.
Classification:   PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
Generic Device Name:   VARIOUS TYPES OF CEMENTED METAL,POLYMER,SEMI-CONSTRAINED HIP PROSTHESIS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY BRIDGEWATER.
Classification:   PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, METAL/POLYMER, MOBILE BEARING
Generic Device Name:   VARIOUS TYPES OF MOBILE BEARING,METAL,POLY,SEMI-CONST,PATELLOFEMOROTIB,KNEE PROS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY BRIDGEWATER.
Classification:   FASTENER, FIXATION, BIODEGRADABLE, HARD TISSUE
Generic Device Name:   VARIOUS TYPES OF BIODEGRADABLE HARD TISSUE FIXATION FASTENER
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY BRIDGEWATER.
Classification:   COMPONENT, CAST
Generic Device Name:   VARIOUS TYPES AND SIZES OF CAST COMPONENTS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  POLAR FIX MATERIAL HOSPITALAR LTDA..
Classification:   APPARATUS, TRACTION, NON-POWERED
Generic Device Name:   VARIOUS MODELS OF NON-POWERED TRACTION APPARATUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZHONGSHAN A&J MEDICAL EQUIPMENT CO., LTD..
Classification:   SPLINT, TRACTION
Generic Device Name:   KENDRICK TRACTION DEVICE
Proprietary Device Name:   K.T.D.
Registered Establishment Name:  EMERGENCY PRODUCTS AND RESEARCH.
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   BONE HOLDING & REPOSITION FORCEPS
Proprietary Device Name:   BONE HOLDING & REPOSITION FORCEPS
Registered Establishment Name:  HONER MEDIZINTECHNIK.
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   SCISSORS
Proprietary Device Name:   SCISSORS
Registered Establishment Name:  THOUSANDS IMPEX.
Classification:   PROBE
Generic Device Name:   PROBE
Proprietary Device Name:   PROBE
Registered Establishment Name:  THOUSANDS IMPEX.
Classification:   RONGEUR
Generic Device Name:   RONGEUR
Proprietary Device Name:   RONGEUR
Registered Establishment Name:  THOUSANDS IMPEX.
Classification:   CALIPER
Generic Device Name:   CALIPER, CLINICAL USE
Proprietary Device Name:   CALIPER, CLINICAL USE
Registered Establishment Name:  THOUSANDS IMPEX.
Classification:   STRIPPER, SURGICAL
Generic Device Name:   VARIOUS TYPES OF STRIPPERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ROLAN INSTRUMENTS GMBH.
Classification:   DYNAMOMETER, NONPOWERED
Generic Device Name:   DYNAMOMETER
Proprietary Device Name:   DYNAMOMETER
Registered Establishment Name:  ROLAN INSTRUMENTS GMBH.
Classification:   REAMER
Generic Device Name:   VARIOUS TYPES OF REAMERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ROLAN INSTRUMENTS GMBH.
Classification:   BIT, DRILL
Generic Device Name:   VARIOUS TYPES OF DRILL BITS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ROLAN INSTRUMENTS GMBH.
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   VARIOUS TYPES OF ORTHOPEDIC SCISSORS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ROLAN INSTRUMENTS GMBH.
Classification:   RONGEUR
Generic Device Name:   VARIOUS TYPES OF RONGEUR
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ROLAN INSTRUMENTS GMBH.
Classification:   AWL
Generic Device Name:   VARIOUS TYPES OF AWLS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ROLAN INSTRUMENTS GMBH.
Classification:   EXTRACTOR
Generic Device Name:   VARIOUS TYPES OF EXTRACTORS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ROLAN INSTRUMENTS GMBH.
Classification:   TREPHINE
Generic Device Name:   TREPHINE
Proprietary Device Name:   TREPHINE
Registered Establishment Name:  ROLAN INSTRUMENTS GMBH.
Classification:   WRENCH
Generic Device Name:   VARIOUS TYPES OF WRENCHES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ROLAN INSTRUMENTS GMBH.
Classification:   PASSER, WIRE, ORTHOPEDIC
Generic Device Name:   WIRE PASSER
Proprietary Device Name:   WIRE PASSER
Registered Establishment Name:  ROLAN INSTRUMENTS GMBH.
Classification:   INSTRUMENT, BENDING OR CONTOURING
Generic Device Name:   VARIOUS TYPES OF BENDING OR CONTOURING INSTRUMENTS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ROLAN INSTRUMENTS GMBH.
Classification:   TWISTER, WIRE
Generic Device Name:   VARIOUS TYPES OF WIRE TWISTERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ROLAN INSTRUMENTS GMBH.
Classification:   SCREWDRIVER
Generic Device Name:   VARIOUS TYPES OF SCREWDRIVERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ROLAN INSTRUMENTS GMBH.
Classification:   SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
Generic Device Name:   VERTEBRAL BODY REPLACEMENT
Proprietary Device Name:   QUANTUM VERTEBRAL BODY REPLACEMENT
Registered Establishment Name:  QUANTUM ORTHOPEDICS, INC..
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENTS
Proprietary Device Name:   MULTIPLE ORTHOPEDIC MANUAL SURGICAL INSTRUMENTS
Registered Establishment Name:  QUANTUM ORTHOPEDICS, INC..
Classification:   SPLINT, TRACTION
Generic Device Name:   HEAD IMMOBILIZERS
Proprietary Device Name:   DYNAMED
Registered Establishment Name:  RED CENTRAL FOAMS, SA DE CV.
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   SCISSORS
Proprietary Device Name:   ONE TEN SURGICAL & DENTAL MFG. CO.
Registered Establishment Name:  ONE TEN SURGICAL & DENTAL MFG. CO..
Classification:   GENERATOR,SHOCK-WAVE,(FOR PAIN RELIEF)
Generic Device Name:   ORTHOPEDIC EXTRACORPOREAL SHOCK WAVE TERAPY
Proprietary Device Name:   ORTHOSPEC ESWT
Registered Establishment Name:  MEDISPEC, LTD..
Classification:   APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
Generic Device Name:   ANTERIOR CERVICAL PLATE
Proprietary Device Name:   NEO ANTERIOR CERVICAL PLATE SYSTEM
Registered Establishment Name:  LIFE SPINE.
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   SCISSORS
Proprietary Device Name:   FIRST LINK MANUFACTURING
Registered Establishment Name:  FIRST LINK MANUFACTURING.
Classification:   SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
Generic Device Name:   VBR SYSTEM
Proprietary Device Name:   LANX VBR SYSTEM
Registered Establishment Name:  LANX, LLC.
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   VARIOUS TYPES OF SURGICAL INSTRUMENTS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  LANX, LLC.
Classification:   ORTHOSIS, SPINAL PEDICLE FIXATION
Generic Device Name:   POSTERIOR LUMBAR SPINE SYSTEM
Proprietary Device Name:   LANX, LLC SPINAL FIXATION SYSTEM
Registered Establishment Name:  LANX, LLC.
Classification:   APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
Generic Device Name:   ANTERIOR CERVICAL SPINE SYSTEM
Proprietary Device Name:   LANX ANTERIOR CERVICAL PLATE SYSTEM
Registered Establishment Name:  LANX, LLC.

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Last Modified: 29 April 2006
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