Biomaterials.info

powered by FreeFind

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


First Page Previous Page Next Page Last Page
Classification:   SCREW, FIXATION, BONE
Generic Device Name:   SNAP-OFF BONE SCREW, NON-STERILE
Proprietary Device Name:   MERETE TWISTCUT SNAP-OFF/DUOTHREADTM BONE SCREW
Registered Establishment Name:  MERETE MEDICAL GMBH.
Classification:   COUNTERSINK
Generic Device Name:   BONE SCREW COUNTERSINK
Proprietary Device Name:   BONE SCREW COUNTERSINK
Registered Establishment Name:  MERETE MEDICAL GMBH.
Classification:   SCREWDRIVER
Generic Device Name:   SCREW DRIVER ORTHOPEDIC
Proprietary Device Name:   SCREW DRIVER ORTHOPEDIC
Registered Establishment Name:  MERETE MEDICAL GMBH.
Classification:   GAUGE, DEPTH
Generic Device Name:   BONE SCREW DEPTH GAUGE
Proprietary Device Name:   BONE SCREW DEPTH GAUGE
Registered Establishment Name:  MERETE MEDICAL GMBH.
Classification:   BIT, DRILL
Generic Device Name:   VARIOUS TWIST DRILLS
Proprietary Device Name:   VARIOUS TWIST DRILLS
Registered Establishment Name:  MERETE MEDICAL GMBH.
Classification:   INSTRUMENT, BENDING OR CONTOURING
Generic Device Name:   VARIOUS TYPES OF BENDING INSTRUMENTS
Proprietary Device Name:   MULTIPLE TYPES OF BENDING INSTRUMENTS
Registered Establishment Name:  MERETE MEDICAL GMBH.
Classification:   APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
Generic Device Name:   SMALL FRAGMENT LOCKING BONE PLATE NON-STERILE
Proprietary Device Name:   MERETE METAFIX SMALL FRAGMENT BONE PLATE SYSTEM
Registered Establishment Name:  MERETE MEDICAL GMBH.
Classification:   APPARATUS, TRACTION, NON-POWERED
Generic Device Name:   THERABOOT
Proprietary Device Name:   THERABOOT
Registered Establishment Name:  AZAR GROUP INTL. INC..
Classification:   FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
Generic Device Name:   BROW LIFT DEVICE & INSTALLATION KIT
Proprietary Device Name:   ENDSTINE (TM)
Registered Establishment Name:  COAPT SYSTEMS, INC..
Classification:   SCREW, FIXATION, BONE
Generic Device Name:   BROW,MIDFACE LIFT DEVICE AND INSTALLATION TOOLS
Proprietary Device Name:   ENDOTINE TRANSBLEPH,TRIPLE,MIDFACE BONE
Registered Establishment Name:  COAPT SYSTEMS, INC..
Classification:   FILLER, BONE VOID, CALCIUM COMPOUND
Generic Device Name:   DEMINERALIZED BONE MATRIX PRODUCTS
Proprietary Device Name:   ORTHOBLAST II PUTTY & GEL
Registered Establishment Name:  ISOTIS ORTHOBIOLOGICS, INC.
Classification:   ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Generic Device Name:   INTRAMEDULLARY NAIL
Proprietary Device Name:   FASSIER-DUVAL TELESCOPIC IM SYSTEM
Registered Establishment Name:  PEGA MEDICAL INC..
Classification:   PIN, FIXATION, THREADED
Generic Device Name:   DISTRACTION PIN
Proprietary Device Name:   NBD DISTRACTION PIN
Registered Establishment Name:  NEW BUSINESS DEVELOPMENT, LLC.
Classification:   APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
Generic Device Name:   ANTERIOR FIXATION DEVICES
Proprietary Device Name:   MULTIPLE, TSRH, CD HORIZON, DYNALOK, ATLANTIS, ZPLATE-ATL, PYRAMID, VERTE-STACK
Registered Establishment Name:  MEDTRONIC SOFAMOR DANEK USA, INC..
Classification:   INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
Generic Device Name:   VARIOUS SURGICAL BURS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  MEDTRONIC SOFAMOR DANEK USA, INC..
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  MEDTRONIC SOFAMOR DANEK USA, INC..
Classification:   CRIMPER, PIN
Generic Device Name:   VARIOUS TENSION CRIMPER
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  MEDTRONIC SOFAMOR DANEK USA, INC..
Classification:   REAMER
Generic Device Name:   MULTIPLE (ORTHOPEDIC REAMERS)
Proprietary Device Name:   MULTIPLE (ORTHOPEDIC REAMERS)
Registered Establishment Name:  MEDTRONIC SOFAMOR DANEK USA, INC..
Classification:   BIT, DRILL
Generic Device Name:   VARIOUS TWIST, BIT DRILLS
Proprietary Device Name:   MULTIPLE TWIST, BIT DRILLS
Registered Establishment Name:  MEDTRONIC SOFAMOR DANEK USA, INC..
Classification:   RONGEUR
Generic Device Name:   VARIOUS (RONGEURS)
Proprietary Device Name:   MULTIPLE (RONGEURS)
Registered Establishment Name:  MEDTRONIC SOFAMOR DANEK USA, INC..
Classification:   EXTRACTOR
Generic Device Name:   MULTIPLE (DRIVER-EXTRACTORS)
Proprietary Device Name:   MULTIPLE (DRIVER-EXTRACTORS)
Registered Establishment Name:  MEDTRONIC SOFAMOR DANEK USA, INC..
Classification:   ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
Generic Device Name:   METALLIC BONE FIXATION DEVICE
Proprietary Device Name:   TSRH SPINAL SYSTEM, CD HORIZON SPINAL SYSTEM
Registered Establishment Name:  MEDTRONIC SOFAMOR DANEK USA, INC..
Classification:   FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH METAL PROSTHESIS, OSTEOINDUCTION
Generic Device Name:   COLLAGEN SPONGE
Proprietary Device Name:   INFUSE BONE GRAFT
Registered Establishment Name:  MEDTRONIC SOFAMOR DANEK USA, INC..
Classification:   FILLER, BONE VOID, CALCIUM COMPOUND
Generic Device Name:   BONE, VOID FILLER
Proprietary Device Name:   MASTERGRAFT (TM) BONE VOID FILLER
Registered Establishment Name:  MEDTRONIC SOFAMOR DANEK USA, INC..
Classification:   SCREW, FIXATION, BONE
Generic Device Name:   BONE SCREW
Proprietary Device Name:   SCREW, FIXATION, BONE
Registered Establishment Name:  MEDTRONIC SOFAMOR DANEK USA, INC..
Classification:   ORTHOSIS, SPINAL INTERVERTEBRAL FUSION
Generic Device Name:   SPINAL FUSION DEVICE
Proprietary Device Name:   INTERFIX TM THREADED FUSION DEVICE
Registered Establishment Name:  MEDTRONIC SOFAMOR DANEK USA, INC..
Classification:   APPLIANCE, FIXATION, SPINAL INTERLAMINAL
Generic Device Name:   INTERLAMINAL CLAMP
Proprietary Device Name:   APOFIX
Registered Establishment Name:  MEDTRONIC SOFAMOR DANEK USA, INC..
Classification:   ORTHOSIS, SPONDYLOISTHESIS SPINAL FIXATION
Generic Device Name:   MULTI-AXIAL SCREW
Proprietary Device Name:   ALPHA POSTERIOR SPINAL SYSTEM
Registered Establishment Name:  MEDTRONIC SOFAMOR DANEK USA, INC..
Classification:   PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
Generic Device Name:   THOMPSON
Proprietary Device Name:   THOMPSON TYPE
Registered Establishment Name:  MEDTRONIC SOFAMOR DANEK USA, INC..
Classification:   PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS CEMENTED, OSTEOPHILIC FINISH
Generic Device Name:   MUELLER
Proprietary Device Name:   MUELLER TYPE
Registered Establishment Name:  MEDTRONIC SOFAMOR DANEK USA, INC..
Classification:   IMPACTOR
Generic Device Name:   IMPACTOR
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  MEDTRONIC SOFAMOR DANEK USA, INC..
Classification:   AWL
Generic Device Name:   AWL
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  MEDTRONIC SOFAMOR DANEK USA, INC..
Classification:   BENDER
Generic Device Name:   VARIOUS BENDERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  MEDTRONIC SOFAMOR DANEK USA, INC..
Classification:   FORK
Generic Device Name:   FORK, FORK HAMMER
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  MEDTRONIC SOFAMOR DANEK USA, INC..
Classification:   PUSHER, SOCKET
Generic Device Name:   SOCKET
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  MEDTRONIC SOFAMOR DANEK USA, INC..
Classification:   PROSTHESIS, INTERVERTEBRAL DISC
Generic Device Name:   INTERVERTEBRAL DISC PROSTHESIS
Proprietary Device Name:   BRYAN TOTAL CERVICAL DISC,PRESTIGE CERVICAL DISC,MAVERICK TOTAL DISC REPLACEMENT
Registered Establishment Name:  MEDTRONIC SOFAMOR DANEK USA, INC..
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   MULTIPLE (SCISSORS)
Proprietary Device Name:   MULTIPLE (SCISSORS)
Registered Establishment Name:  MEDTRONIC SOFAMOR DANEK USA, INC..
Classification:   COUNTERSINK
Generic Device Name:   COUNTERSINK
Proprietary Device Name:   COUNTERSINK
Registered Establishment Name:  MEDTRONIC SOFAMOR DANEK USA, INC..
Classification:   CUTTER, WIRE
Generic Device Name:   VARIOUS TYPES OF ORTHOPEDIC WIRE CUTTERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  MEDTRONIC SOFAMOR DANEK USA, INC..
Classification:   WRENCH
Generic Device Name:   VARIOUS TYPES OF ORTHOPEDIC WRENCHES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  MEDTRONIC SOFAMOR DANEK USA, INC..

First Page Previous Page Next Page Last Page




Last Modified: 29 April 2006
http://www.biomaterials.info
Sitemap
Link | Link | Link | Link | Link | Link | Link | Link