Arthrex DynaNite Nitinol Staple

Arthrex DynaNite Nitinol Staple is an FDA 510(k)-cleared medical device (K172052) 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 December 12, 2017. Regulation: 8.