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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:   APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
Generic Device Name:   ANTERIOR CERVICAL PLATING SYSTEM
Proprietary Device Name:   ALINE ANTERIOR CERVICAL PLATING SYSTEM
Registered Establishment Name:  UNITED STATES SURGICAL.
Classification:   GAUGE, DEPTH
Generic Device Name:   SAME
Proprietary Device Name:   SAME
Registered Establishment Name:  HOLMED CORP..
Classification:   WASHER, BOLT NUT
Generic Device Name:   SAME
Proprietary Device Name:   SAME
Registered Establishment Name:  HOLMED CORP..
Classification:   REAMER
Generic Device Name:   SAME
Proprietary Device Name:   SAME
Registered Establishment Name:  HOLMED CORP..
Classification:   BURR, ORTHOPEDIC
Generic Device Name:   SAME
Proprietary Device Name:   SAME
Registered Establishment Name:  HOLMED CORP..
Classification:   PIN, FIXATION, SMOOTH
Generic Device Name:   NONE
Proprietary Device Name:   NONE
Registered Establishment Name:  HOLMED CORP..
Classification:   IMPACTOR
Generic Device Name:   SAME
Proprietary Device Name:   SAME
Registered Establishment Name:  HOLMED CORP..
Classification:   EXTRACTOR
Generic Device Name:   SAME
Proprietary Device Name:   SAME
Registered Establishment Name:  HOLMED CORP..
Classification:   AWL
Generic Device Name:   SAME
Proprietary Device Name:   SAME
Registered Establishment Name:  HOLMED CORP..
Classification:   TREPHINE
Generic Device Name:   SAME
Proprietary Device Name:   SAME
Registered Establishment Name:  HOLMED CORP..
Classification:   INSTRUMENT, COMPRESSION
Generic Device Name:   SAME
Proprietary Device Name:   SAME
Registered Establishment Name:  HOLMED CORP..
Classification:   PASSER
Generic Device Name:   SAME
Proprietary Device Name:   SAME
Registered Establishment Name:  HOLMED CORP..
Classification:   DRIVER, PROSTHESIS
Generic Device Name:   SAME
Proprietary Device Name:   SAME
Registered Establishment Name:  HOLMED CORP..
Classification:   TEMPLATE
Generic Device Name:   SAME
Proprietary Device Name:   SAME
Registered Establishment Name:  HOLMED CORP..
Classification:   COUNTERSINK
Generic Device Name:   SAME
Proprietary Device Name:   SAME
Registered Establishment Name:  HOLMED CORP..
Classification:   TAP, BONE
Generic Device Name:   SAME
Proprietary Device Name:   SAME
Registered Establishment Name:  HOLMED CORP..
Classification:   WRENCH
Generic Device Name:   SAME
Proprietary Device Name:   SAME
Registered Establishment Name:  HOLMED CORP..
Classification:   TAMP
Generic Device Name:   SAME
Proprietary Device Name:   SAME
Registered Establishment Name:  HOLMED CORP..
Classification:   PASSER, WIRE, ORTHOPEDIC
Generic Device Name:   SAME
Proprietary Device Name:   SAME
Registered Establishment Name:  HOLMED CORP..
Classification:   PUSHER, SOCKET
Generic Device Name:   SAME
Proprietary Device Name:   SAME
Registered Establishment Name:  HOLMED CORP..
Classification:   INSTRUMENT, BENDING OR CONTOURING
Generic Device Name:   SAME
Proprietary Device Name:   SAME
Registered Establishment Name:  HOLMED CORP..
Classification:   TWISTER, WIRE
Generic Device Name:   SAME
Proprietary Device Name:   SAME
Registered Establishment Name:  HOLMED CORP..
Classification:   SCREWDRIVER
Generic Device Name:   SAME
Proprietary Device Name:   SAME
Registered Establishment Name:  HOLMED CORP..
Classification:   BRACE, DRILL
Generic Device Name:   SAME
Proprietary Device Name:   SAME
Registered Establishment Name:  HOLMED CORP..
Classification:   CUTTER, WIRE
Generic Device Name:   SAME
Proprietary Device Name:   SAME
Registered Establishment Name:  HOLMED CORP..
Classification:   PIN, FIXATION, THREADED
Generic Device Name:   NONE
Proprietary Device Name:   NONE
Registered Establishment Name:  HOLMED CORP..
Classification:   CALIPER
Generic Device Name:   SAME
Proprietary Device Name:   SAME
Registered Establishment Name:  HOLMED CORP..
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   VARIOUS TYPES OF SCISSORS
Proprietary Device Name:   HOLMED HAND HELD INSTRUMENTS
Registered Establishment Name:  HOLMED CORP..
Classification:   IMPLANT, FIXATION DEVICE, SPINAL
Generic Device Name:   SPINAL IMPLANT
Proprietary Device Name:   NONE
Registered Establishment Name:  HOLMED CORP..
Classification:   SCREW, FIXATION, BONE
Generic Device Name:   BONE ANCHOR
Proprietary Device Name:   SCREW, FIXATION, BONE
Registered Establishment Name:  BOSTON SCIENTIFIC CORP..
Classification:   DRIVER, PROSTHESIS
Generic Device Name:   BONE ANCHOR DRIVER
Proprietary Device Name:   PRECISION TWIST, PRECISION TACK, VESICA
Registered Establishment Name:  BOSTON SCIENTIFIC CORP..
Classification:   FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  BOSTON SCIENTIFIC CORP..
Classification:   ARTHROSCOPE
Generic Device Name:   VARIOUS
Proprietary Device Name:   ARTHREX ARTHROSCOPIC SURGICAL INSTRUMENTS
Registered Establishment Name:  TNCO, INC..
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   VARIOUS SURGICAL INSTRUMENTS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SMITH & NEPHEW, INC..
Classification:   PROBE
Generic Device Name:   VARIOUS SURGICAL INSTRUMENTS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SMITH & NEPHEW, INC..
Classification:   TREPHINE
Generic Device Name:   VARIOUS TREPHINE DRILLS AND ACCESSORIES
Proprietary Device Name:   ACUFEX TREPHINE
Registered Establishment Name:  SMITH & NEPHEW, INC..
Classification:   COMPONENT, TRACTION, NON-INVASIVE
Generic Device Name:   VARIOUS TRACTION COMPONENTS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SMITH & NEPHEW, INC..
Classification:   FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
Generic Device Name:   NONABSORBABLE SUTURE ANCHOR AND ACCESSORIES
Proprietary Device Name:   TAG BONE ANCHOR
Registered Establishment Name:  SMITH & NEPHEW, INC..
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   VARIOUS GUIDEWIRES, PASSING PINS, AND GUIDING SYSTEMS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SMITH & NEPHEW, INC..
Classification:   TEMPLATE
Generic Device Name:   VARIOUS TEMPLATES AND ACCESSORIES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SMITH & NEPHEW, INC..

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Last Modified: 29 April 2006
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