DISTAL HUMERAL PLATES WITH ANGULAR STABILITY

DISTAL HUMERAL PLATES WITH ANGULAR STABILITY is an FDA 510(k)-cleared medical device (K080184) manufactured by I.T.S. Implantat-Technologie-Systeme 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 March 25, 2008. Regulation: 8.