510(k) K191045 · NKB Thoracolumbosacral Pedicle Screw System
Salvo Spine System
| Applicant | Spine Wave, Inc., Shelton CT, US |
| Decision | Substantially Equivalent, Jul 10, 2019 |
| Received | Apr 19, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191045
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.