ORTHOFIX ACP (ANTERIOR CERVICAL PLATE SYSTEM)

ORTHOFIX ACP (ANTERIOR CERVICAL PLATE SYSTEM) is an FDA 510(k)-cleared medical device (K121658) manufactured by Orthofix, 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 July 19, 2012. Regulation: 8.