I.T.S. EXTREMITY FIXATION SYSTEMS

I.T.S. EXTREMITY FIXATION SYSTEMS is an FDA 510(k)-cleared medical device (K131722) manufactured by I.T.S. GmbH. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 6, 2013. Regulation: 8.