510(k) K260989 ยท NKB Thoracolumbosacral Pedicle Screw System
Varion Thoracolumbar Fixation System
| Applicant | Kyocera Medical Technologies Inc. (KMTI), Redlands CA, US |
| Decision | Substantially Equivalent, May 15, 2026 |
| Received | Mar 25, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K260989
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.