Harvester SI: Sacroiliac Fixation System

Harvester SI: Sacroiliac Fixation System is an FDA 510(k)-cleared medical device (K203780) manufactured by Spinus International, 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 March 22, 2021. Regulation: 8.