Medtronic Sofamor Danek ATLANTIS® Anterior Cervical Plate System. Catalog #3125515

Vendor/Manufacturer: Medtronic Sofamor Danek

Product/Product Line: ATLANTIS® Anterior Cervical Plate System

Vendor/Manufacturer Catalog #: 3125515

Global Unique Device (GUD) Primary Device Identifier Number: 00613994241252

Global Unique Device (GUD) Device Description:

SCREW 3125515 4.5 X 15 SELF DRILL VAR

Global Medical Device Nomenclature (GMDN) Preferred Term Name:

Spinal bone screw, non-bioabsorbable

Global Medical Device Nomenclature (GMDN) Definition:

A small, threaded rod with a slotted head intended to be used for internal spinal fixation by being screwed into the spine to hold a stabilization device (e.g., rod, plate) to bone; it 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 available in various types, including pedicle and transfacet, and is typically used to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities.

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 Submissions: 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

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