PCA(R) E SERIES HIP SYSTEM (CEMENTLESS USE)

PCA(R) E SERIES HIP SYSTEM (CEMENTLESS USE) is an FDA 510(k)-cleared medical device (K925172) 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 21, 1994. Regulation: 8.