IMPLEX HEP ACETABULAR CUP SYSTEM, CEMENTED

IMPLEX HEP ACETABULAR CUP SYSTEM, CEMENTED is an FDA 510(k)-cleared medical device (K971705) manufactured by Implex Corp.. 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 5, 1997. Regulation: 8.