AETOS Shoulder System - CONCELOC Glenoids

AETOS Shoulder System - CONCELOC Glenoids is an FDA 510(k)-cleared medical device (K254084) 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 5, 2026. Regulation: 8.