GLENOID INTELLIGENT REUSABLE INSTRUMENT SYSTEM (GLENOID IRIS)

GLENOID INTELLIGENT REUSABLE INSTRUMENT SYSTEM (GLENOID IRIS) is an FDA 510(k)-cleared medical device (K142072) 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 November 23, 2014. Regulation: 8.