ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM

ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM is an FDA 510(k)-cleared medical device (K993855) manufactured by Danek 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 December 14, 1999. Regulation: 8.