Prime E-CLASS XLPE Liner

Prime E-CLASS XLPE Liner is an FDA 510(k)-cleared medical device (K181598) manufactured by Microport Orthopedics, 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 13, 2018. Regulation: 8.