Arthrex Modular Glenoid System-Titanium Glenosphere

Arthrex Modular Glenoid System-Titanium Glenosphere is an FDA 510(k)-cleared medical device (K212415) manufactured by Arthrex, 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 16, 2021. Regulation: 8.