FOUNDATION KNEE AUGMENTATION BLOCKS

FOUNDATION KNEE AUGMENTATION BLOCKS is an FDA 510(k)-cleared medical device (K941306) manufactured by Encore Orthopedics, 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 February 7, 1995. Regulation: 8.