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Stryker VariAx Distal Radius Locking Plate System. Catalog #54-25291


Vendor/Manufacturer: Stryker

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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