VANGUARD 360 OSSEOTI TIBIAL SLEEVE AUGMENT

VANGUARD 360 OSSEOTI TIBIAL SLEEVE AUGMENT is an FDA 510(k)-cleared medical device (K140883) manufactured by Biomet, Inc.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 29, 2014. Regulation: 8.