Vendor/Manufacturer: Stryker
Product/Product Line: VariAx Distal Radius Locking Plate System
Vendor/Manufacturer Catalog #: 53-27716E
Global Unique Device (GUD) Primary Device Identifier Number: 07613154914135
Global Unique Device (GUD) Device Description:
PARTIALLY THREADED LOCKING PEG, T7
Global Medical Device Nomenclature (GMDN) Preferred Term Name:
Orthopaedic bone screw, non-bioabsorbable, non-sterile
Global Medical Device Nomenclature (GMDN) Definition:
A small, non-sterile, threaded rod with a slotted head typically used for internal orthopaedic fracture fixation by being screwed into bone to hold plates or nails to bone or to provide direct interfragmentary stabilization of bone, or it may fasten soft tissue to bone; it is made of a material that cannot be chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). Screws available are: cortical, cancellous, malleolar, scaphoid, partially-threaded and fully-threaded, self-tapping, and cannulated. A "lag screw" can be any of these used to obtain compression. This device must 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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