8MM FORGED CEMENTED STEM

8MM FORGED CEMENTED STEM is an FDA 510(k)-cleared medical device (K991227) 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 May 31, 1999. Regulation: 8.