510(k) K254148 ยท OLO Orthopedic Stereotaxic Instrument
VERTICALE GPS Instruments
| Applicant | Silony Medical GmbH, Leinfelden-Echterdingen, DE |
| Decision | Substantially Equivalent, Feb 19, 2026 |
| Received | Dec 22, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K254148
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.