INVISION TOTAL ANKLE REVISION SYSTEM

INVISION TOTAL ANKLE REVISION SYSTEM is an FDA 510(k)-cleared medical device (K142117) 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 March 24, 2015. Regulation: 8.