510(k) K193423 · NKB Thoracolumbosacral Pedicle Screw System
VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0
| Applicant | Icotec AG, 9450 Altstaetten (Sg), CH |
| Decision | Substantially Equivalent, May 22, 2020 |
| Received | Dec 9, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K193423
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 19, 2022 | Icotec Ag VADER Pedicle System Torque Wrench, Hudson Coupling, 12 Nm, REF 42-702 Terminated |
NKB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.