510(k) K254158 ยท OLO Orthopedic Stereotaxic Instrument
SPINEART Navigation Instrument System
| Applicant | Spineart SA, Plan-Les-Ouates, CH |
| Decision | Substantially Equivalent, Apr 9, 2026 |
| Received | Dec 22, 2025 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K254158
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.