Medtronic Sofamor Danek ATLANTIS Translation. SCREW. Two-Level.

Vendor/Manufacturer: Medtronic Sofamor Danek Product/Product Line: ATLANTIS Translation Screw Vendor/Manufacturer Catalog #: Global Unique Device (GUD) Primary Device Identifier Number: 00613994241139 Global Unique Device (GUD) Device Description: SCREW 3120514 4.0 X 14 SELF DRILL VAR Global Medical Device Nomenclature (GMDN) Preferred Term Name: Bone-screw internal spinal fixation system, non-sterile Category 1: Spine Category 2: Cervical Plate & Screw Systems Category 3: Screw Category 4: Two Level Quantity of "Each"es needed in each System/Set: 6 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: 1. ZEPHIR® Anterior Cervical System 2. ATLANTIS® Anterior Cervical Plate System