EPIPHYSIS SCREW

EPIPHYSIS SCREW is an FDA 510(k)-cleared medical device (K043410) 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 February 23, 2005. Regulation: 8.