K253444
- 510(k) number
- K253444
- Device name
- EUROPA Posterior Cervical Fusion Navigated Instruments
- Applicant
- MiRus, LLC GA · US
- Product code
- OLO — Orthopedic Stereotaxic Instrument
- Decision date
- 2026-03-18
- Date received
- 2025-10-02
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K253444.pdf
Official FDA record: K253444
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.