ANATOMIC PEEK PTC CERVICAL FUSION SYSTEM

ANATOMIC PEEK PTC CERVICAL FUSION SYSTEM is an FDA 510(k)-cleared medical device (K133653) 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 April 27, 2014. Regulation: 8.