ORTHOHELIX SYNDESMOSIS FIXATION DEVICES

ORTHOHELIX SYNDESMOSIS FIXATION DEVICES is an FDA 510(k)-cleared medical device (K132733) 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 January 2, 2014. Regulation: 8.