510(k) K182478 ยท NKB Thoracolumbosacral Pedicle Screw System
Whistler Modular Pedicle Screw System
| Applicant | Evolution Spine, LLC, Dallas TX, US |
| Decision | Substantially Equivalent, Jan 15, 2019 |
| Received | Sep 10, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182478
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.