K253080
- 510(k) number
- K253080
- Device name
- AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)
- Applicant
- Suzhou and Science & Technology Development Corp. CN
- Product code
- HSB — Rod, Fixation, Intramedullary And Accessories
- Decision date
- 2026-06-18
- Date received
- 2025-09-23
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K253080.pdf
Official FDA record: K253080
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.