ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM

ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM is an FDA 510(k)-cleared medical device (K130640) 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 June 3, 2013. Regulation: 8.