ENCORE FULLY COATED HIP

ENCORE FULLY COATED HIP is an FDA 510(k)-cleared medical device (K992109) 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 August 11, 1999. Regulation: 8.