Integra Salto Total Ankle System

Integra Salto Total Ankle System is an FDA 510(k)-cleared medical device (K182878) 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 December 17, 2018. Regulation: 8.