OLECRA INTRAMEDULLARY FIXATION SYSTEM

OLECRA INTRAMEDULLARY FIXATION SYSTEM is an FDA 510(k)-cleared medical device (K110322) manufactured by Mylad Orthopedic Solutions. 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 3, 2011. Regulation: 8.