K243950
- 510(k) number
- K243950
- Device name
- ARVIS® Shoulder
- Applicant
- Kico Knee Innovation Company Pty, Ltd. AU
- Product code
- SBF — Orthopedic Augmented Reality
- Decision date
- 2025-01-13
- Date received
- 2024-12-23
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 3.1 MB · U.S. public domain
Also available from FDA: K243950.pdf
Official FDA record: K243950
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.