K254148
- 510(k) number
- K254148
- Device name
- VERTICALE GPS Instruments
- Applicant
- Silony Medical GmbH DE
- Product code
- OLO — Orthopedic Stereotaxic Instrument
- Decision date
- 2026-02-19
- Date received
- 2025-12-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K254148.pdf
Official FDA record: K254148
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.