MAK OSS FEMORAL KNEE COMPONENTS

MAK OSS FEMORAL KNEE COMPONENTS is an FDA 510(k)-cleared medical device (K131393) manufactured by Biomet Orthopedics Corp.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 23, 2013. Regulation: 8.