X-PAC® N-GAGE™ Lumbar Plate System

X-PAC® N-GAGE™ Lumbar Plate System is an FDA 510(k)-cleared medical device (K250602) manufactured by Expanding Innovations, Inc.. 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 19, 2025. Regulation: 8.