R3 Anteverted Liners

R3 Anteverted Liners is an FDA 510(k)-cleared medical device (K182535) 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 November 18, 2018. Regulation: 8.