510(k) K160069 ยท HSB Rod, Fixation, Intramedullary And Accessories
Sonoma Fibula Repair System
| Applicant | Sonoma Orthopedics Products, Inc., Buffalo Grove IL, US |
| Decision | Substantially Equivalent, Mar 10, 2016 |
| Received | Jan 13, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160069
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.