12MM AND 13MM TIBIAL NAILS

12MM AND 13MM TIBIAL NAILS is an FDA 510(k)-cleared medical device (K130625) manufactured by Advanced Orthopaedic Solutions, 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 27, 2013. Regulation: 8.