ORTHOFIX ANKLE HINDFOOT NAILING SYSTEM

ORTHOFIX ANKLE HINDFOOT NAILING SYSTEM is an FDA 510(k)-cleared medical device (K141571) manufactured by Orthofix Srl. 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 11, 2014. Regulation: 8.