ZION Anterior Cervical Fixation System

ZION Anterior Cervical Fixation System is an FDA 510(k)-cleared medical device (K160702) manufactured by Astura Medical. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 22, 2016. Regulation: 8.