Vantage Total Ankle Flat Cut Talar Components

Vantage Total Ankle Flat Cut Talar Components is an FDA 510(k)-cleared medical device (K183343) manufactured by Exactech, 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 March 31, 2019. Regulation: 8.