510(k) K253990 · NKB Thoracolumbosacral Pedicle Screw System
KHEIRON® Spinal Fixation System, including patient specific K-ROD
| Applicant | S.M.A.I.O, Saint-Priest, FR |
| Decision | Substantially Equivalent, Jan 7, 2026 |
| Received | Dec 12, 2025 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K253990
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.