BI-CENTRIC ENDOPROSTHESES

BI-CENTRIC ENDOPROSTHESES is an FDA 510(k)-cleared medical device (K770184) manufactured by Howmedica 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 February 7, 1977. Regulation: 8.