510(k) K153453 ยท NKB Thoracolumbosacral Pedicle Screw System
Inertia Pedicle Screw and Deformity Correxxion System
| Applicant | Nexxt Spine, LLC, Noblesville IN, US |
| Decision | Substantially Equivalent, Apr 26, 2016 |
| Received | Nov 30, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153453
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.