Clearance Summary
Genesys Spine Sacroiliac Joint Fusion System with Navigation received FDA 510(k) clearance under submission number K233595, sponsored by Genesys Spine. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2024-03-29.
- Submission: K233595
- Applicant / Sponsor: Genesys Spine
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.4560
- Decision date: 2024-03-29
Classification & Regulation
This clearance is catalogued under FDA product code OLO and 21 CFR 882.4560, within the Neurology review panel as a Class II device.