INVISION Total Ankle Revision System

INVISION Total Ankle Revision System is an FDA 510(k)-cleared medical device (K180730) manufactured by Wrightmedicaltechnologyinc. 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 10, 2018. Regulation: 8.