DISTALOCK TIBIAL IM NAIL SYSTEM

DISTALOCK TIBIAL IM NAIL SYSTEM is an FDA 510(k)-cleared medical device (K132830) manufactured by Dgimed Ortho, 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 January 5, 2014. Regulation: 8.