510(k) K250622
K250622 is an FDA 510(k) premarket notification submitted by Ortho Solutions UK , Ltd. for the device "Succession AFN System". The FDA issued a decision of Substantially Equivalent on August 7, 2025. The device falls under product code HSB (Rod, Fixation, Intramedullary And Accessories), a Class II device regulated under 21 CFR 888.3020. Ortho Solutions UK , Ltd. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 7, 2025
- Date Received
- February 28, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Rod, Fixation, Intramedullary And Accessories
- Device Class
- Class II
- Regulation Number
- 888.3020
- Review Panel
- OR
- Submission Type