LUX Expandable Lumbar Interbody System

LUX Expandable Lumbar Interbody System is an FDA 510(k)-cleared medical device (K253583) manufactured by Xenix Medical. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 22, 2026. Regulation: 8.