Amendia Interbody Fusion Devices

Amendia Interbody Fusion Devices is an FDA 510(k)-cleared medical device (K160924) 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 November 7, 2016. Regulation: 8.