Amendia Stand-Alone Cervical System

Amendia Stand-Alone Cervical System is an FDA 510(k)-cleared medical device (K152972) manufactured by Amendia, 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 January 13, 2016. Regulation: 8.