SIMPACT Sacroiliac Joint Fixation System GX Navigation Instruments

SIMPACT Sacroiliac Joint Fixation System GX Navigation Instruments is an FDA 510(k)-cleared medical device (K260571) manufactured by Life Spine, Inc.. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 1, 2026. Regulation: 8.