Clearance Summary
Succession AFN System received FDA 510(k) clearance under submission number K250622, sponsored by Ortho Solutions UK , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2025-08-07.
- Submission: K250622
- Applicant / Sponsor: Ortho Solutions UK , Ltd.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3020
- Decision date: 2025-08-07
Classification & Regulation
This clearance is catalogued under FDA product code HSB and 21 CFR 888.3020, within the Orthopedic review panel as a Class II device.