510(k) K163627 ยท HSB Rod, Fixation, Intramedullary And Accessories
Shotel Ankle Arthrodesis Nail System
| Applicant | Biopro, Inc., Port Huron MI, US |
| Decision | Substantially Equivalent, Sep 14, 2017 |
| Received | Dec 22, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K163627
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.