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:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   GENERAL SCISSORS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  MED-LINE INSTRUMENTS.
Classification:   ORTHOSIS, SPINAL PEDICLE FIXATION
Generic Device Name:   PEDICLE SCREW SPINAL SYSTEM
Proprietary Device Name:   MONARCH SPINE SYSTEM
Registered Establishment Name:  DEPUY SPINE SARL.
Classification:   APPLIANCE, FIXATION, SPINAL INTERLAMINAL
Generic Device Name:   SPINAL INTERLAMINAL FIXATION ORTHOSIS
Proprietary Device Name:   MONARCH SPINE SYSTEM
Registered Establishment Name:  DEPUY SPINE SARL.
Classification:   ORTHOSIS, SPONDYLOISTHESIS SPINAL FIXATION
Generic Device Name:   PEDICLE SCREW SPINAL SYSTEM
Proprietary Device Name:   MONARCH SPINE SYSTEM
Registered Establishment Name:  DEPUY SPINE SARL.
Classification:   SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
Generic Device Name:   SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
Proprietary Device Name:   DEVEX MESH SYSTEM
Registered Establishment Name:  DEPUY SPINE SARL.
Classification:   ARTHROSCOPE
Generic Device Name:   ARTHROSCOPE/ORTHOPEDIC
Proprietary Device Name:   TRANS-SACRAL SPINAL ACCESS AND PREPARATION KIT
Registered Establishment Name:  TRANS1 INCORPORATED.
Classification:   APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
Generic Device Name:   ANTERIOR SPINAL FIXATION DEVICE
Proprietary Device Name:   TRANS1 AXIAL FIXATION SYSTEM, AXIALIF SYSTEM
Registered Establishment Name:  TRANS1 INCORPORATED.
Classification:   ORTHOPEDIC IMPLANT MATERIAL
Generic Device Name:   VARIOUS TYPES OF ORTHOPEDIC IMPLANTS
Proprietary Device Name:   SAMPEDRO
Registered Establishment Name:  INDUSTRIAS MEDICAS SAMPEDRO S.A..
Classification:   GONIOMETER, NONPOWERED
Generic Device Name:   ACUMAR INCLINOMETER
Proprietary Device Name:   ACUMAR
Registered Establishment Name:  ACUMAR TECHNOLOGY.
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   SCISSORS
Proprietary Device Name:   CENTRAL SURGICAL CO.
Registered Establishment Name:  CENTRAL SURGICAL CO..
Classification:   COMPONENT, CAST
Generic Device Name:   CAST PAD, UNDER CAST PADDING
Proprietary Device Name:   NONE
Registered Establishment Name:  AMERICAN HOSPITAL PRODUCTS.
Classification:   APPLIANCE, FIXATION, SPINAL INTERLAMINAL
Generic Device Name:   SPINAL INTERLAMINAL FIXATION ORTHOSIS
Proprietary Device Name:   MEGA SPINE
Registered Establishment Name:  BK MEDITECH CO., LTD..
Classification:   SPLINT, TRACTION
Generic Device Name:   VARIOUS MODELS OF SPLINTS
Proprietary Device Name:   FROOM SPLINT
Registered Establishment Name:  RK FROOM & CO., INC..
Classification:   BIT, DRILL
Generic Device Name:   DRILL
Proprietary Device Name:   MITEK DRILL
Registered Establishment Name:  DEPUY MITEK, A JOHNSON & JOHNSON COMPANY.
Classification:   STAPLE, FIXATION, BONE
Generic Device Name:   APPLIANCE FOR RECONSTRUCTION OF BONE AND SOFT TISSUE
Proprietary Device Name:   MITEK ANCHOR
Registered Establishment Name:  DEPUY MITEK, A JOHNSON & JOHNSON COMPANY.
Classification:   SCREW, FIXATION, BONE
Generic Device Name:   APPLIANCE FOR RECONSTRUCTION OF BONE AND SOFT TISSUE
Proprietary Device Name:   MITEK ANCHOR
Registered Establishment Name:  DEPUY MITEK, A JOHNSON & JOHNSON COMPANY.
Classification:   FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
Generic Device Name:   FASTNER, FIXATION, BIODEGRADABLE SOFT TISSUE
Proprietary Device Name:   FASTENER, FIXATION, BIODEGRADABLE SOFT TISSUE
Registered Establishment Name:  DEPUY MITEK, A JOHNSON & JOHNSON COMPANY.
Classification:   GAUGE, DEPTH
Generic Device Name:   DEPTH GUAGE
Proprietary Device Name:   DEPTH GUAGE
Registered Establishment Name:  DEPUY MITEK, A JOHNSON & JOHNSON COMPANY.
Classification:   KNIFE, ORTHOPEDIC
Generic Device Name:   VARIOUS TYPES OF ORTHOPEDIC KNIVES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY MITEK, A JOHNSON & JOHNSON COMPANY.
Classification:   EXTRACTOR
Generic Device Name:   VARIOUS TYPES OF REMOVAL TOOLS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY MITEK, A JOHNSON & JOHNSON COMPANY.
Classification:   TAP, BONE
Generic Device Name:   VARIOUS BONE TAPS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY MITEK, A JOHNSON & JOHNSON COMPANY.
Classification:   WASHER, BOLT NUT
Generic Device Name:   VARIOUS SIZES OF SPIKED WASHERS
Proprietary Device Name:   SPIKED WASHER
Registered Establishment Name:  DEPUY MITEK, A JOHNSON & JOHNSON COMPANY.
Classification:   REAMER
Generic Device Name:   VARIOUS ORTHOPEDIC REAMERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY MITEK, A JOHNSON & JOHNSON COMPANY.
Classification:   AWL
Generic Device Name:   VARIOUS AWLS, NON-STERILE
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY MITEK, A JOHNSON & JOHNSON COMPANY.
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   VARIOUS TYPES OF MANUAL ORTHOPEDIC SURGICAL INSTRUMENTS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY MITEK, A JOHNSON & JOHNSON COMPANY.
Classification:   FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
Generic Device Name:   FASTENER, FIXATION, NON-BIODEGRADABLE, SOFT TISSUE
Proprietary Device Name:   FASTENER, FIXATION, NON-BIODEGRADABLE, SOFT TISSUE
Registered Establishment Name:  DEPUY MITEK, A JOHNSON & JOHNSON COMPANY.
Classification:   PIN, FIXATION, THREADED
Generic Device Name:   CROSS PINS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY MITEK, A JOHNSON & JOHNSON COMPANY.
Classification:   PIN, FIXATION, SMOOTH
Generic Device Name:   CROSS PINS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY MITEK, A JOHNSON & JOHNSON COMPANY.
Classification:   ARTHROSCOPE
Generic Device Name:   SUTURE BONE FASTENER INSTRUMENT SET
Proprietary Device Name:   ROC SUTURE BONE FASTENER INSTRUMENT SET
Registered Establishment Name:  DEPUY MITEK, A JOHNSON & JOHNSON COMPANY.
Classification:   SCREWDRIVER
Generic Device Name:   VARIOUS ORTHOPEDIC SCREWDRIVERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY MITEK, A JOHNSON & JOHNSON COMPANY.
Classification:   PASSER
Generic Device Name:   SUTURE PASSER
Proprietary Device Name:   MITEK SUTURE PASSER
Registered Establishment Name:  DEPUY MITEK, A JOHNSON & JOHNSON COMPANY.
Classification:   PROBE
Generic Device Name:   VARIOUS TYPES OF ORTHOPEDIC PROBES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY MITEK, A JOHNSON & JOHNSON COMPANY.
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   KIT FOR BROKEN SCREW REMOVAL
Proprietary Device Name:   SURGICAL KIT FOR SPINAL REVISIONS
Registered Establishment Name:  R. W. JOHNSON.
Classification:   STAPLE, FIXATION, BONE
Generic Device Name:   BONE FIXATION STAPLE
Proprietary Device Name:   UNI-CLIP
Registered Establishment Name:  EVOLUTIS.
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   SCISSORS
Proprietary Device Name:   SCISSORS, ORTHOPEDIC, SURGICAL ORTHOPEDIC
Registered Establishment Name:  MACY TRADERS.
Classification:   RONGEUR
Generic Device Name:   RONGEUR
Proprietary Device Name:   RONGEUR ORTHOPEDIC
Registered Establishment Name:  MACY TRADERS.
Classification:   PROBE
Generic Device Name:   PROBE
Proprietary Device Name:   PROBE ORTHOPEDIC
Registered Establishment Name:  MACY TRADERS.
Classification:   CALIPER
Generic Device Name:   CALIPER CLINICAL USE
Proprietary Device Name:   CALIPER ORTHOPEDIC
Registered Establishment Name:  MACY TRADERS.
Classification:   CALIPER
Generic Device Name:   CALIPER, CLINICAL USE
Proprietary Device Name:   CALIPER, CLINICAL USE
Registered Establishment Name:  UNIWORTH ENTERPRISES.
Classification:   RONGEUR
Generic Device Name:   RONGEUR
Proprietary Device Name:   RONGEUR
Registered Establishment Name:  UNIWORTH ENTERPRISES.

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