dynaMX(TM) Nitinol Compression Screw

dynaMX(TM) Nitinol Compression Screw is an FDA 510(k)-cleared medical device (K160427) manufactured by Mx Orthopedics, Corp.. 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 2, 2016. Regulation: 8.