FDA Product Code OUR: Sacroiliac Joint Fixation
Under FDA product code OUR, sacroiliac joint fixation devices are cleared for the surgical stabilization and fusion of the sacroiliac joint.
The sacroiliac joint connects the spine to the pelvis and is a significant source of lower back and buttock pain. OUR devices — typically minimally invasive implant systems of screws or rods — immobilize the joint to promote bone fusion and relieve chronic pain unresponsive to conservative treatment.
OUR devices are Class II medical devices, regulated under 21 CFR 888.3040 and reviewed by the FDA Orthopedic panel.
Leading manufacturers include SI-BONE, Inc., SurGenTec, LLC and L & K Biomed Co., Ltd..
List of Sacroiliac Joint Fixation devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Sacroiliac Joint Fixation devices (product code OUR). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Orthopedic FDA review panel. Browse all Orthopedic devices →