B-P HEMISPHERICAL ACETABULAR COMPONENT

B-P HEMISPHERICAL ACETABULAR COMPONENT is an FDA 510(k)-cleared medical device (K963101) manufactured by Endotec, 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 11, 1997. Regulation: 8.