I.T.S. PELVIC RECONSTRUCTION SYSTEM

I.T.S. PELVIC RECONSTRUCTION SYSTEM is an FDA 510(k)-cleared medical device (K063166) 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 December 21, 2006. Regulation: 8.