Medtronic Sofamor Danek ATLANTIS Translation. SCREW. One-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: 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:

1. ZEPHIR® Anterior Cervical System

2. ATLANTIS® Anterior Cervical Plate System