UHMWPE COMPONENTS-CHANGE IN PACKAGING

UHMWPE COMPONENTS-CHANGE IN PACKAGING is an FDA 510(k)-cleared medical device (K940743) manufactured by Depuy, 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 September 17, 1995. Regulation: 8.