MAXLOCK EXTREME ELBOW FRACTURE SYSTEM

MAXLOCK EXTREME ELBOW FRACTURE SYSTEM is an FDA 510(k)-cleared medical device (K141301) manufactured by Orthohelix Surgical Designs, 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 July 10, 2014. Regulation: 8.