SYNTHES HIGH TIBIAL OSTEOTOMY (HTO) SYSTEM

SYNTHES HIGH TIBIAL OSTEOTOMY (HTO) SYSTEM is an FDA 510(k)-cleared medical device (K962894) 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 December 16, 1996. Regulation: 8.