SmartBase for Arthrex Glenoid IRIS

SmartBase for Arthrex Glenoid IRIS is an FDA 510(k)-cleared medical device (K153215) manufactured by Custom Orthopaedic Solutions, 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 February 18, 2016. Regulation: 8.