510(k) K180458 ยท NKB Thoracolumbosacral Pedicle Screw System
FOCUS Pedicle Screw System
| Applicant | Nvision Biomedical Technologies, LLC, San Antonio TX, US |
| Decision | Substantially Equivalent, Apr 17, 2018 |
| Received | Feb 20, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180458
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.