510(k) K183091 ยท NKB Thoracolumbosacral Pedicle Screw System
Elaris Pedicle Screw System
| Applicant | Spinewelding AG, Schlieren, CH |
| Decision | Substantially Equivalent, Aug 2, 2019 |
| Received | Nov 6, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K183091
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.