510(k) K253080— AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)

Substantially Equivalent

Suzhou and Science & Technology Development Corp.

Clearance details

Applicant: Suzhou and Science & Technology Development Corp.
Product code: Code HSB
Advisory panel: Orthopedic
Date received: 2025-09-23
Decision date: 2026-06-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Zhangjiagang, CN

Adverse 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, 2020-01-01 through 2026-04-23. 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.