KEYSTONE HIP SYSTEM CALCAR REPLACEMENT BODY AND BUILD UP

KEYSTONE HIP SYSTEM CALCAR REPLACEMENT BODY AND BUILD UP is an FDA 510(k)-cleared medical device (K020170) 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 February 10, 2002. Regulation: 8.