Auxano® Wedge Fixation System

Auxano® Wedge Fixation System is an FDA 510(k)-cleared medical device (K251791) manufactured by Auxano Medical, 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 September 24, 2025. Regulation: 8.