AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)
Device Facts
| Record ID | K253080 |
|---|---|
| Device Name | AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02) |
| Applicant | Suzhou and Science & Technology Development Corp. |
| Product Code | HSB · Orthopedic |
| Decision Date | Jun 18, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 888.3020 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.
