ARTHREX PLA TISSUETAK, MODEL # AR-1940 BU

ARTHREX PLA TISSUETAK, MODEL # AR-1940 BU is an FDA 510(k)-cleared medical device (K990340) 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 January 27, 2000. Regulation: 8.