ANATOMIC PEEK PTC Cervical Fusion System

ANATOMIC PEEK PTC Cervical Fusion System is an FDA 510(k)-cleared medical device (K160528) 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 March 27, 2016. Regulation: 8.