SYNTHES (USA) ELBOW HINGE FIXATOR

SYNTHES (USA) ELBOW HINGE FIXATOR is an FDA 510(k)-cleared medical device (K063832) manufactured by Synthes (Usa). 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 6, 2007. Regulation: 8.