FOUNDATION POROUS COATED FLARED RIM SHELL

FOUNDATION POROUS COATED FLARED RIM SHELL is an FDA 510(k)-cleared medical device (K974095) 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 January 27, 1998. Regulation: 8.