Integra Total Ankle Replacement System

Integra Total Ankle Replacement System is an FDA 510(k)-cleared medical device (K151459) manufactured by Ascension Orthopedics. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 30, 2015. Regulation: 8.