510(k) K262091 ยท NKB Thoracolumbosacral Pedicle Screw System
FRAXION Spinal Fixation System
| Applicant | Ortler Global Tibbi Gerecler Anonim Sirketi, Ankara, TR |
| Decision | Substantially Equivalent, Sep 17, 2026 |
| Received | Jun 22, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K262091
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.