510(k) K160167 ยท HSB Rod, Fixation, Intramedullary And Accessories
DePuy Synthes TFNA Augmentation System
| Applicant | Synthes (USA) Products, LLC, West Chester PA, US |
| Decision | Substantially Equivalent, Sep 26, 2016 |
| Received | Jan 27, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160167
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 1, 2024 | Synthes (USA) Products LLC TFNA Femoral Nail 9mm, right, 130, L 235mm-Intended for temporary fixation and stabilization of proximal femur fractures.
Part Number: 04.037.944S Open, Classified |
HSB | None listed |
| Mar 1, 2024 | Synthes (USA) Products LLC TFNA Femoral Nail 11mm, right, 130, L 235mm-Intended for temporary fixation and stabilization of proximal femur fractures.
Part Number: 04.037.144S Open, Classified |
HSB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.