FOUNDATION METAL-BACKED PATELLA

FOUNDATION METAL-BACKED PATELLA is an FDA 510(k)-cleared medical device (K932246) 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 July 21, 1994. Regulation: 8.