510(k) K230512 ยท HSB Rod, Fixation, Intramedullary And Accessories
Gamma4 System
| Applicant | Stryker GmbH, Mahwah NJ, US |
| Decision | Substantially Equivalent, Jun 9, 2023 |
| Received | Feb 24, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K230512
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.