510(k) K253080
AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02) by
Suzhou and Science & Technology Development Corp.
— Product Code HSB
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 18, 2026
- Date Received
- September 23, 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