AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)— 510(k) K253080
Substantially EquivalentSuzhou and Science & Technology Development Corp.
FDA 510(k) clearance K253080 for AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02), Substantially Equivalent on 2026-06-18. Applicant: Suzhou and Science & Technology Development Corp.. Device class: 2.
Summary
Suzhou and Science & Technology Development Corp.'s AND Medical Femoral Nail System comes in two models, PFNA01 and PFNA02. It's filed under HSB, intramedullary fixation rods and accessories, and the record doesn't say how the models differ.
Class II, 21 CFR 888.3020. Orthopedic is both the classification panel and the review panel, and it came in as a Traditional 510(k).
The applicant filed from Zhangjiagang, China. Review took 268 calendar days (September 23, 2025 to June 18, 2026).
Clearance details
- Applicant
- Suzhou and Science & Technology Development Corp.
- Product code
- Product code HSB
- Device class
- Class 2
- Regulation
- 21 CFR 888.3020
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Zhangjiagang, CN
Recent devices under product code HSB
view allAdverse events under product code HSB
product code HSB- Death
- 49
- Injury
- 12,083
- Malfunction
- 6,561
- Other
- 1
- Total
- 18,694
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.