K243980
- 510(k) number
- K243980
- Device name
- ARVIS Surgical Navigation System
- Applicant
- Kico Knee Innovation Company Pty Limited AU
- Product code
- SBF — Orthopedic Augmented Reality
- Decision date
- 2025-03-21
- Date received
- 2024-12-23
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K243980.pdf
Official FDA record: K243980
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.