SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS)

SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS) is an FDA 510(k)-cleared medical device (K190069) manufactured by Arrowhead De, LLC. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 13, 2019. Regulation: 8.