Varion Thoracolumbar Fixation System

Varion Thoracolumbar Fixation System is an FDA 510(k)-cleared medical device (K260989) manufactured by Kyocera Medical Technologies Inc. (KMTI). 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 14, 2026. Regulation: 8.