ARTHREX UNIVERS II CA HEADS

ARTHREX UNIVERS II CA HEADS is an FDA 510(k)-cleared medical device (K130675) 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 October 29, 2013. Regulation: 8.