ORION ANTERIOR CERVICAL PLATE SYSTEM

ORION ANTERIOR CERVICAL PLATE SYSTEM is an FDA 510(k)-cleared medical device (K973854) manufactured by 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 15, 1998. Regulation: 8.