FOUNDATION NON-POROUS STEM

FOUNDATION NON-POROUS STEM is an FDA 510(k)-cleared medical device (K935449) 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 March 29, 1995. Regulation: 8.