ASTEL NON-METAL BACKED ACETABULAR CUP FOR CEMENTED

ASTEL NON-METAL BACKED ACETABULAR CUP FOR CEMENTED is an FDA 510(k)-cleared medical device (K901240) manufactured by Med-Tek 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 25, 1990. Regulation: 8.