HOWMEDICA(R) ACETABULAR COMP PACK/MANUF METH CHANGE

HOWMEDICA(R) ACETABULAR COMP PACK/MANUF METH CHANGE is an FDA 510(k)-cleared medical device (K934060) 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 August 17, 1995. Regulation: 8.