Hyper-C Anterior Cervical Plate System

Hyper-C Anterior Cervical Plate System is an FDA 510(k)-cleared medical device (K150759) manufactured by Degen 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 July 27, 2015. Regulation: 8.