OR3O Dual Mobility Liners

OR3O Dual Mobility Liners is an FDA 510(k)-cleared medical device (K232667) manufactured by Smith & Nephew, 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 October 26, 2023. Regulation: 8.