BI-CENTRIC BI-POLAR ENDOPROSTHESIS

BI-CENTRIC BI-POLAR ENDOPROSTHESIS is an FDA 510(k)-cleared medical device (K810062) 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 January 25, 1981. Regulation: 8.