Arthrex Univers II Shoulder Prosthesis System: Titanium Humeral Heads

Arthrex Univers II Shoulder Prosthesis System: Titanium Humeral Heads is an FDA 510(k)-cleared medical device (K182799) 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 March 7, 2019. Regulation: 8.