Vendor/Manufacturer: Stryker
Product/Product Line: VariAx Distal Radius Locking Plate System
Vendor/Manufacturer Catalog #: 54-25291
Global Unique Device (GUD) Primary Device Identifier Number: 07613153068341
Global Unique Device (GUD) Device Description:
Dorsal DR Plate Standard, Left
Global Medical Device Nomenclature (GMDN) Preferred Term Name:
Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
Global Medical Device Nomenclature (GMDN) Definition:
A non-sterile assembly of implantable devices designed for the stabilization of fractured/surgically-cut bones of the limbs (long bones), their appendages (hands, feet), pelvis, craniomaxillofacial bones, and/or for limb-joint fusion. It typically consists of a set of bone fixation plates, screws, wires, and pins made of materials that cannot be chemically degraded or absorbed via natural body processes (e.g., implant grade metal, surgical steel, titanium alloy, or carbon fibre). It may also include instruments for the attachment of the implants such as screwdrivers or drills. This device is intended to be sterilized prior to use.
FDA Regulation Medical Specialty:
Orthopedic Devices - Prosthetic Devices
FDA Regulation Number: 888.3040
FDA Regulation Description Classification Name:
Smooth or threaded metallic bone fixation fastener
FDA Classification Product Code(s): HRS, HWC
FDA Classification Product Code Device Name(s):
HRS: Plate, Fixation, Bone
HWC: Screw, Fixation, Bone
FDA Premarket Submission(s): K141430
The Stryker VariAx Distal Radius Locking Plate System is
SUBSTANTIALLY EQUIVALENT to the following product(s):
For more information, please visit us at Infonomics.com
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