Align Anterior Ankle Fusion Plate

Align Anterior Ankle Fusion Plate is an FDA 510(k)-cleared medical device (K160191) manufactured by Extremity Medical, LLC. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 24, 2016. Regulation: 8.