Legion Inserts with JRNY Lock

Legion Inserts with JRNY Lock is an FDA 510(k)-cleared medical device (K220896) 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 April 25, 2022. Regulation: 8.