Athena II Cervical Plate System

Athena II Cervical Plate System is an FDA 510(k)-cleared medical device (K183409) manufactured by Medyssey 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 February 10, 2019. Regulation: 8.