PCA (R) TIBIAL BONE WEDGES

PCA (R) TIBIAL BONE WEDGES is an FDA 510(k)-cleared medical device (K904170) 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 October 16, 1990. Regulation: 8.