K230700
- 510(k) number
- K230700
- Device name
- RIWOtrack Navigation System
- Applicant
- Fiagon GmbH DE
- Product code
- OLO — Orthopedic Stereotaxic Instrument
- Decision date
- 2023-11-20
- Date received
- 2023-03-13
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K230700.pdf
Official FDA record: K230700
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.