SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM

SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM is an FDA 510(k)-cleared medical device (K120070) 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 20, 2012. Regulation: 8.