Arthrex DynaNite K-Wire

Arthrex DynaNite K-Wire is an FDA 510(k)-cleared medical device (K200068) 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 June 28, 2020. Regulation: 8.