FOUNDATION 9MM FORGED CEMENTED STEM

FOUNDATION 9MM FORGED CEMENTED STEM is an FDA 510(k)-cleared medical device (K961890) 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 June 13, 1996. Regulation: 8.