UNIFY(R) DYNAMIC ANTERIOR CERVICAL PLATE SYSTEM

UNIFY(R) DYNAMIC ANTERIOR CERVICAL PLATE SYSTEM is an FDA 510(k)-cleared medical device (K133567) manufactured by Globus Medical, 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 February 19, 2014. Regulation: 8.