STRUXXURE®-L and STRUXXURE®-A Plate System

STRUXXURE®-L and STRUXXURE®-A Plate System is an FDA 510(k)-cleared medical device (K202192) manufactured by Nexxt Spine, 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 16, 2020. Regulation: 8.