R3 HA Coated Acetabular Shells

R3 HA Coated Acetabular Shells is an FDA 510(k)-cleared medical device (K201701) 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 5, 2020. Regulation: 8.