PRESS-FIT FLARED SHELL

PRESS-FIT FLARED SHELL is an FDA 510(k)-cleared medical device (K960633) 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 September 30, 1996. Regulation: 8.