Hintermann Series H2 Total Ankle System

Hintermann Series H2 Total Ankle System is an FDA 510(k)-cleared medical device (K171004) manufactured by Dt Medtech, LLC. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 6, 2017. Regulation: 8.