IMPLEX REPLACEMENT ACETABULAR CUP INSERT

IMPLEX REPLACEMENT ACETABULAR CUP INSERT is an FDA 510(k)-cleared medical device (K964882) 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 March 12, 1997. Regulation: 8.