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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:   SCREW, FIXATION, BONE
Generic Device Name:   VARIOUS TYPES AND SIZES OF BONE SCREWS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SYNTHES MEZZOVICO.
Classification:   WASHER, BOLT NUT
Generic Device Name:   VARIOUS TYPES AND SIZES OF BOLTS,NUTS,OR WASHERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SYNTHES MEZZOVICO.
Classification:   PLATE, FIXATION, BONE
Generic Device Name:   VARIOUS TYPES AND SIZES OF BONE PLATES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SYNTHES MEZZOVICO.
Classification:   ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
Generic Device Name:   VARIOUS TYPES AND SIZES OF DEGENERATIVE DISC DISEASE SPINAL PEDICLE FIXATION ORT
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SYNTHES MEZZOVICO.
Classification:   PIN, FIXATION, SMOOTH
Generic Device Name:   VARIOUS TYPES AND SIZES OF SMOOTH FIXATION PINS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SYNTHES MEZZOVICO.
Classification:   NAIL, FIXATION, BONE
Generic Device Name:   VARIOUS TYPES AND SIZES OF BONE FIXATION NAILS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SYNTHES MEZZOVICO.
Classification:   APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
Generic Device Name:   VARIOUS TYPES AND SIZES OF MULTIPLE COMPONENT NAIL/BLADE/PLATE COMBINATION FIXA
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SYNTHES MEZZOVICO.
Classification:   APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, SINGLE COMPONENT
Generic Device Name:   VARIOUS TYPES AND SIZES OF SINGLE COMPONENT NAIL/BLADE/PLATE COMBINATION FIXATIO
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SYNTHES MEZZOVICO.
Classification:   APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
Generic Device Name:   VARIOUS TYPES AND SIZES OF SPINAL INTERVERTEBRAL BODY FIXATION APPLIANCES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SYNTHES MEZZOVICO.
Classification:   APPLIANCE, FIXATION, SPINAL INTERLAMINAL
Generic Device Name:   VARIOUS TYPES AND SIZES OF SPINAL INTERLAMINAL FIXATION APPLIANCES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SYNTHES MEZZOVICO.
Classification:   ORTHOSIS, SPINAL PEDICLE FIXATION
Generic Device Name:   VARIOUS TYPES AND SIZES OF SPINAL PEDICLE FIXATION ORTHOSES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SYNTHES MEZZOVICO.
Classification:   ORTHOSIS, SPONDYLOISTHESIS SPINAL FIXATION
Generic Device Name:   VARIOUS TYPES AND SIZES OF SPONDYLOLISTHESIS SPINAL FIXATION ORTHOSES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SYNTHES MEZZOVICO.
Classification:   SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
Generic Device Name:   VARIOUS TYPES AND SIZES OF SPINAL VERTEBRAL BODY REPLACEMENT DEVICES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SYNTHES MEZZOVICO.
Classification:   FILLER, BONE VOID, CALCIUM COMPOUND
Generic Device Name:   FILLER, BONE VOID, CALCIUM COMPOUND
Proprietary Device Name:   STERLING CANCELLOUS CHIPS, STERLING CANCELLOUS CUBES
Registered Establishment Name:  REGENERATION TECHNOLOGIES, INC..
Classification:   SCREW, FIXATION, BONE
Generic Device Name:   INTERFERENCE SCREW
Proprietary Device Name:   STERLING INTERFERENCE SCREW ST
Registered Establishment Name:  REGENERATION TECHNOLOGIES, INC..
Classification:   SCREWDRIVER
Generic Device Name:   MODULAR HANDLE, SCREWDRIVER
Proprietary Device Name:   STERLING INTERFERENCE SCREW ST HEX DRIVER
Registered Establishment Name:  REGENERATION TECHNOLOGIES, INC..
Classification:   PASSER, WIRE, ORTHOPEDIC
Generic Device Name:   INTERFERENCE SCREW GUIDEWIRE
Proprietary Device Name:   STERLING INTERFERENCE SCREW GUIDEWIRE
Registered Establishment Name:  REGENERATION TECHNOLOGIES, INC..
Classification:   TAP, BONE
Generic Device Name:   HT TAP, ST TAP
Proprietary Device Name:   STERLING INTERFERENCE SCREW ST TAP
Registered Establishment Name:  REGENERATION TECHNOLOGIES, INC..
Classification:   SPLINT, TRACTION
Generic Device Name:   TRACTION SPLINT
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DAVID MEDICAL PRODUCTS (SUZHOU) CO., LTD..
Classification:   HALTER, HEAD, TRACTION
Generic Device Name:   HEAD TRACTION
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DAVID MEDICAL PRODUCTS (SUZHOU) CO., LTD..
Classification:   AWL
Generic Device Name:   AWL
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SCIENT'X USA, INC..
Classification:   BENDER
Generic Device Name:   ROD AND PLATE BENDERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SCIENT'X USA, INC..
Classification:   BIT, DRILL
Generic Device Name:   DRILL BIT
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SCIENT'X USA, INC..
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   VARIOUS MANUAL ORTHOPEDIC INSTRUMENTS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SCIENT'X USA, INC..
Classification:   PROBE
Generic Device Name:   PROBE
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SCIENT'X USA, INC..
Classification:   RONGEUR
Generic Device Name:   RONGEUR
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SCIENT'X USA, INC..
Classification:   SCREWDRIVER
Generic Device Name:   SCREWDRIVER
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SCIENT'X USA, INC..
Classification:   TAP, BONE
Generic Device Name:   VARIOUS BONE TAPS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SCIENT'X USA, INC..
Classification:   GAUGE, DEPTH
Generic Device Name:   DEPTH GAUGE
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SCIENT'X USA, INC..
Classification:   WRENCH
Generic Device Name:   VARIOUS WRENCHES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SCIENT'X USA, INC..
Classification:   SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
Generic Device Name:   VERTEBRAL BODY REPLACEMENT DEVICE
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SCIENT'X USA, INC..
Classification:   ORTHOSIS, SPONDYLOISTHESIS SPINAL FIXATION
Generic Device Name:   VARIOUS SPINAL IMPLANT FIXATION DEVICES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SCIENT'X USA, INC..
Classification:   APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
Generic Device Name:   SPINAL FIXATION SYSTEM
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SCIENT'X USA, INC..
Classification:   ORTHOSIS, SPINAL PEDICLE FIXATION
Generic Device Name:   PEDICLE SCREW SYSTEM
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SCIENT'X USA, INC..
Classification:   APPLIANCE, FIXATION, SPINAL INTERLAMINAL
Generic Device Name:   VARIOUS SPINAL INTERLAMINAL FIXATION DEVICES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SCIENT'X USA, INC..
Classification:   ACCESSORIES,ARTHROSCOPIC
Generic Device Name:   SUTURE CUTTER OF KNOT PUSHER
Proprietary Device Name:   TENO FIX ACP SUTURE CUTTER / KNOT PUSHER
Registered Establishment Name:  ORTHEON MEDICAL, LLC..
Classification:   APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
Generic Device Name:   ANTERIOR CERVICAL PLATE
Proprietary Device Name:   VERTEVIEW ANTERIOR CERVICAL PLATE
Registered Establishment Name:  ATLAS SPINE, LLC.
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   CABLE TENSIONER & PROVISIONAL CRIMP
Proprietary Device Name:   MULTIPLE VARIOUS
Registered Establishment Name:  ATLAS SPINE, LLC.
Classification:   CALIPER
Generic Device Name:   CLINICAL USE CALIPER
Proprietary Device Name:   CALIPER
Registered Establishment Name:  BESTECH INTERNATIONAL.
Classification:   RONGEUR
Generic Device Name:   RONGEUR
Proprietary Device Name:   RONGEUR
Registered Establishment Name:  BESTECH INTERNATIONAL.

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Last Modified: 29 April 2006
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