BDH UNIPOLAR FEMORAL COMPONENT A2

BDH UNIPOLAR FEMORAL COMPONENT A2 is an FDA 510(k)-cleared medical device (K833403) manufactured by Carbomedics, 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 January 9, 1984. Regulation: 8.