K253921
- 510(k) number
- K253921
- Device name
- VERTICALE® Navigation Instruments
- Applicant
- Silony Medical GmbH DE
- Product code
- OLO — Orthopedic Stereotaxic Instrument
- Decision date
- 2026-06-26
- Date received
- 2025-12-08
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 3.1 MB · U.S. public domain
Also available from FDA: K253921.pdf
Official FDA record: K253921
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.