INS HILDEN TIBIAL ARZZT

INS HILDEN TIBIAL ARZZT is an FDA 510(k)-cleared medical device (K133166) manufactured by Truemed Group, 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 5, 2014. Regulation: 8.