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:   CUTTER, WIRE
Generic Device Name:   MANUAL ORTHOPEDIC SURGICAL INSTRUMENTS (WIRE CUTTER)
Proprietary Device Name:   LIFECARE SURGICAL INSTRUMENTS (MULTIPLE)
Registered Establishment Name:  LIFECARE SURGICAL INSTRUMENTS.
Classification:   INSTRUMENT, CAST APPLICATION/REMOVAL, MANUAL
Generic Device Name:   MANUAL ORTHOPEDIC SURGICAL INSTRUMENTS(MA CAST APPLICATION/REMOVAL INSTRUMENT)
Proprietary Device Name:   LIFECARE SURGICAL INSTRUMENTS(MULTIPLE)
Registered Establishment Name:  LIFECARE SURGICAL INSTRUMENTS.
Classification:   FILLER, BONE VOID, CALCIUM COMPOUND
Generic Device Name:   BONE VOID FILLER
Proprietary Device Name:   BIOSORB RESORBABLE FILLER
Registered Establishment Name:  SCIENCE FOR BIOMATERIALS.
Classification:   SCREW, FIXATION, BONE
Generic Device Name:   BONE FIXATION SCREW
Proprietary Device Name:   MULTIPLE TYPE OF LIGAFIX
Registered Establishment Name:  SCIENCE FOR BIOMATERIALS.
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   MULTIPLE TYPE OF ORTHOPEDIC SURGICAL INSTRUMENT
Proprietary Device Name:   MULTIPLE TYPE OF LIGAFIX,COMPLETE INSTRUMENTION SET
Registered Establishment Name:  SCIENCE FOR BIOMATERIALS.
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   VARIOUS TYPES OF ORTHOPEDIC SURGICAL SCISSORS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  WELMED INSTRUMENTS COMPANY.
Classification:   RONGEUR
Generic Device Name:   VARIOUS TYPES OF RONGEURS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  WELMED INSTRUMENTS COMPANY.
Classification:   FILE
Generic Device Name:   VARIOUS TYPES OF SURGICAL FILES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  WELMED INSTRUMENTS COMPANY.
Classification:   PASSER, WIRE, ORTHOPEDIC
Generic Device Name:   VARIOUS TYPES OF ORTHOPEDIC WIRE PASSERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  WELMED INSTRUMENTS COMPANY.
Classification:   PROBE
Generic Device Name:   VARIOUS TYPES OF SURGICAL PROBES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  WELMED INSTRUMENTS COMPANY.
Classification:   TWISTER, WIRE
Generic Device Name:   VARIOUS TYPES OF WIRE TWISTERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  WELMED INSTRUMENTS COMPANY.
Classification:   CUTTER, WIRE
Generic Device Name:   VARIOUS TYPES OF WIRE CUTTERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  WELMED INSTRUMENTS COMPANY.
Classification:   BRACE, DRILL
Generic Device Name:   VARIOUS TYPES OF DRILL BRACES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  WELMED INSTRUMENTS COMPANY.
Classification:   INSTRUMENT, CAST APPLICATION/REMOVAL, MANUAL
Generic Device Name:   VARIOUS TYPES OF CAST APPLICATION/REMOVAL INSTRUMENTS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  WELMED INSTRUMENTS COMPANY.
Classification:   ORTHOSIS, SPINAL PEDICLE FIXATION
Generic Device Name:   PEDICLE SCREW SPINAL SYSTEM
Proprietary Device Name:   CAPLESS PEDICLE SCREW SYSTEM
Registered Establishment Name:  X-SPINE SYSTEMS, INC..
Classification:   APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
Generic Device Name:   SPIDER CERVICAL PLATING SYSTEM-ANTERIOR COMPACT PLATE SYSTEM
Proprietary Device Name:   SPIDER CERVICAL PLATING SYSTEM-ANTERIOR COMPACT PLATE SYSTEM
Registered Establishment Name:  X-SPINE SYSTEMS, INC..
Classification:   PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER
Generic Device Name:   KNEE JOINT
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ORTEK AG.
Classification:   PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
Generic Device Name:   KNEE JOINT
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ORTEK AG.
Classification:   RONGEUR
Generic Device Name:   RONGEURS
Proprietary Device Name:   MTL INSTRUMENTS (PVT), LTD.
Registered Establishment Name:  MTL INSTRUMENTS (PVT), LTD..
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   SCISSORS
Proprietary Device Name:   MTL INSTRUMENTS (PVT), LTD.
Registered Establishment Name:  MTL INSTRUMENTS (PVT), LTD..
Classification:   APPLIANCE, FIXATION, SPINAL INTERLAMINAL
Generic Device Name:   PEDICLE SCREW SYSTEM
Proprietary Device Name:   LTD POLYAXIAL FIXATION SYSTEM
Registered Establishment Name:  US SPINAL TECHNOLOGIES, LLC..
Classification:   APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
Generic Device Name:   PEDICLE SCREW SYSTEM
Proprietary Device Name:   LTD POLYAXIAL FIXATION SYSTEM
Registered Establishment Name:  US SPINAL TECHNOLOGIES, LLC..
Classification:   ORTHOSIS, SPONDYLOISTHESIS SPINAL FIXATION
Generic Device Name:   PEDICLE SCREW FIXATION SYSTEM
Proprietary Device Name:   LTD POLYAXIAL FIXATION SYSTEM
Registered Establishment Name:  US SPINAL TECHNOLOGIES, LLC..
Classification:   ORTHOSIS, SPINAL PEDICLE FIXATION
Generic Device Name:   PEDICLE SCREW SYSTEM
Proprietary Device Name:   LTD POLYAXIAL FIXATION SYSTEM
Registered Establishment Name:  US SPINAL TECHNOLOGIES, LLC..
Classification:   SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
Generic Device Name:   TITANIUM MESH
Proprietary Device Name:   ATALIA TITANIUM SURGICAL MESH
Registered Establishment Name:  US SPINAL TECHNOLOGIES, LLC..
Classification:   MIXER, CEMENT, FOR CLINICAL USE
Generic Device Name:   VARIOUS TYPES OF BOWLS SURGICAL USE
Proprietary Device Name:   BOWL
Registered Establishment Name:  HEALTHPOT INDUSTRIES.
Classification:   APPLIANCE, FIXATION, SPINAL INTERLAMINAL
Generic Device Name:   ROD AND SCREW SPINAL INSTRUMENTATION
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  BLACKSTONE MEDICAL, INC..
Classification:   SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
Generic Device Name:   VERTEBRAL BODY REPLACEMENT DEVICE
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  BLACKSTONE MEDICAL, INC..
Classification:   ORTHOSIS, SPINAL PEDICLE FIXATION
Generic Device Name:   SPINAL FIXATION SYSTEM
Proprietary Device Name:   BLACKSTONE SPINAL FIXATION SYSTEM
Registered Establishment Name:  BLACKSTONE MEDICAL, INC..
Classification:   ORTHOSIS, SPONDYLOISTHESIS SPINAL FIXATION
Generic Device Name:   SPINAL FIXATION SYSTEM
Proprietary Device Name:   BLACKSTONE SPINAL FIXATION SYSTEM
Registered Establishment Name:  BLACKSTONE MEDICAL, INC..
Classification:   RONGEUR
Generic Device Name:   VARIOUS TYPES OF RONGEURS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  BLACKSTONE MEDICAL, INC..
Classification:   APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
Generic Device Name:   SPINAL FIXATION SYSTEM
Proprietary Device Name:   BLACKSTONE SPINAL FIXATION SYSTEM
Registered Establishment Name:  BLACKSTONE MEDICAL, INC..
Classification:   BENDER
Generic Device Name:   BENDER
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  BLACKSTONE MEDICAL, INC..
Classification:   IMPACTOR
Generic Device Name:   IMPACTOR
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  BLACKSTONE MEDICAL, INC..
Classification:   PROBE
Generic Device Name:   PROBE
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  BLACKSTONE MEDICAL, INC..
Classification:   ARTHROSCOPE
Generic Device Name:   NUCLEUS PULPOSIS EVACTUATOR SYSTEM
Proprietary Device Name:   NUCLEUS PULPOSIS EVACTUATOR SYSTEM
Registered Establishment Name:  BLACKSTONE MEDICAL, INC..
Classification:   PLATE, FIXATION, BONE
Generic Device Name:   VARIOUS TYPES & SIZES OF BONE PLATES
Proprietary Device Name:   STANFORD MEDICAL DEVICES
Registered Establishment Name:  STANFORD MEDICAL DEVICES, INC..
Classification:   SCREWDRIVER
Generic Device Name:   VARIOUS TYPES & SIZES OF DRIVER INSTRUMENTATION
Proprietary Device Name:   STANFORD MEDICAL DEVICES
Registered Establishment Name:  STANFORD MEDICAL DEVICES, INC..
Classification:   SCREW, FIXATION, BONE
Generic Device Name:   VARIOUS TYPES & SIZES OF BONE SCREWS
Proprietary Device Name:   STANFORD MEDICAL DEVICES
Registered Establishment Name:  STANFORD MEDICAL DEVICES, INC..
Classification:   PIN, FIXATION, THREADED
Generic Device Name:   SCARF SCREW & WEIL SCREW, COMPRESSION SCREW
Proprietary Device Name:   DARCO FOREFOOT RECONSTRUCTION
Registered Establishment Name:  O.M.T. OBERFLACHEN-UND MATERIALTECHNOLOGIE GMBH.

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