Arthrex DynaNite Nitinol Staples

Arthrex DynaNite Nitinol Staples is an FDA 510(k)-cleared medical device (K243742) 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 30, 2025. Regulation: 8.