METAGEN HIGH TIBIAL OSTEOTOMY SYSTEM

METAGEN HIGH TIBIAL OSTEOTOMY SYSTEM is an FDA 510(k)-cleared medical device (K963700) manufactured by Metagen, LLC. 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 11, 1997. Regulation: 8.