510(k) K150184 ยท NKB Thoracolumbosacral Pedicle Screw System
Dymaxeon Spine System
| Applicant | Back 2 Basics Direct, LLC, Independence OH, US |
| Decision | Substantially Equivalent, Jun 15, 2015 |
| Received | Jan 27, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K150184
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 29, 2018 | Back 2 Basics Direct LLC Dymaxeon 5.5 Curved Rod Size 5.5 x 110mm (Yellow), Model Number 06.6441B
Product Usage:
The Dymaxeon Spine System is intended to provide immobilization and stabilization of spinal segments in skeleta Terminated |
NKB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.