Insignia™ Anterior Cervical Plate System

Insignia™ Anterior Cervical Plate System is an FDA 510(k)-cleared medical device (K200995) manufactured by Alphatec Spine, 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 May 20, 2020. Regulation: 8.