Arthrex Univers Apex, Size 5 Stem

Arthrex Univers Apex, Size 5 Stem is an FDA 510(k)-cleared medical device (K153115) 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 22, 2015. Regulation: 8.