SIMPACT Sacroiliac Joint Fixation System

SIMPACT Sacroiliac Joint Fixation System is an FDA 510(k)-cleared medical device (K212903) manufactured by Life Spine, 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 December 14, 2021. Regulation: 8.