510(k) K252962 · OLO Orthopedic Stereotaxic Instrument
DYNAMIS Navigation System
| Applicant | Promethean Restorative, LLC, Castle Rock CO, US |
| Decision | Substantially Equivalent, Jan 12, 2026 |
| Received | Sep 16, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252962
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.