510(k) K192930 ยท NKB Thoracolumbosacral Pedicle Screw System
Dymaxeon Spine System
| Applicant | Back 2 Basics Direct, LLC, Independence OH, US |
| Decision | Substantially Equivalent, May 12, 2020 |
| Received | Oct 17, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192930
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.