Medtronic Sofamor Danek ATLANTIS® Anterior Cervical Plate System. Catalog #6190042

Vendor/Manufacturer: Medtronic Sofamor Danek

Product/Product Line: ATLANTIS® Anterior Cervical Plate System

Vendor/Manufacturer Catalog #: 6190042

Global Unique Device (GUD) Primary Device Identifier Number: 00763000868116

Global Unique Device (GUD) Device Description:

PLATE 6190042 ANTERIOR CERVICAL 42.5MM

Global Medical Device Nomenclature (GMDN) Preferred Term Name:

Spinal fixation plate, non-bioabsorbable

Global Medical Device Nomenclature (GMDN) Definition:

A small implantable sheet of solid material that is attached to the spine with screws for spinal immobilization and is made of a material that is not chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is typically used to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities (e.g., during anterior/posterior cervical, anterior/posterior lumbar, thoracolumbar, and occipital fixation procedures).

Category 1: Spine

Category 2: Cervical Plate & Screw Systems

Category 3: Plate

Category 4: Two Level

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

FDA Premarket Submission: K063100

The Medtronic Sofamor Danek ATLANTIS® Anterior Cervical Plate System is

SUBSTANTIALLY EQUIVALENT to the following products:

1. Medtronic Sofamor Danek ZEPHIR® Anterior Cervical System

2. Medtronic Sofamor Danek ATLANTIS™ - previous version

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