AxCess® Expandable Interbody System

AxCess® Expandable Interbody System is an FDA 510(k)-cleared medical device (K243739) manufactured by Elliquence, 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 January 23, 2025. Regulation: 8.