ATLANTIS Anterior Cervical Plate System

ATLANTIS Anterior Cervical Plate System is an FDA 510(k)-cleared medical device (K152623) manufactured by Medtronic Sofamor Danek USA, Inc.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 11, 2015. Regulation: 8.