Clearance Summary
FFX Facet Fixation System received FDA 510(k) clearance under submission number K252153, sponsored by Sc Medica. The device was reviewed via the Traditional premarket notification pathway and assigned to the Unknown review panel. The statutory decision date of record is 2025-10-16.
- Submission: K252153
- Applicant / Sponsor: Sc Medica
- Clearance pathway: Traditional
- Review panel: Unknown
- Device class:
- Decision date: 2025-10-16
Classification & Regulation
This clearance is catalogued under FDA product code MRW , within the Unknown review panel as a device.