Vendor/Manufacturer: Stryker
Product/Product Line: AVIATOR Screw
Vendor/Manufacturer Catalog #: 48824014
Global Unique Device (GUD) Primary Device Identifier Number: 07613252152606
Global Unique Device (GUD) Device Description:
VARIABLE, SELF-DRILLING SCREW
Global Medical Device Nomenclature (GMDN) Preferred Term Name:
Spinal fixation plate, non-bioabsorbable
Category 1: Spine
Category 2: Cervical Plate & Screw Systems
Category 3: Screw
Category 4: One Level
Quantity of "Each"es needed in each System/Set: 4
FDA Regulation Medical Specialty: Orthopedic Devices - Prosthetic Devices
FDA Regulation Number: 888.3060
FDA Regulation Description Classification Name:
Spinal intervertebral body fixation orthosis
FDA Classification Product Code: KWQ
FDA Classification Product Code Device Name:
Appliance, Fixation, Spinal Intervertebral Body
SUBSTANTIALLY EQUIVALENT to the following products:
Comments