510(k) K253921 · OLO Orthopedic Stereotaxic Instrument
VERTICALE® Navigation Instruments
| Applicant | Silony Medical GmbH, Leinfelden-Echterdingen, DE |
| Decision | Substantially Equivalent, Jun 26, 2026 |
| Received | Dec 8, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253921
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.