Univers Rivers Shoulder Prosthesis System

Univers Rivers Shoulder Prosthesis System is an FDA 510(k)-cleared medical device (K142863) 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 24, 2014. Regulation: 8.