ARVIS® Shoulder is an AI-enabled medical device from Kico Knee Innovation Company Pty Ltd, listed by FDA (510(k), K243950) with a decision date of 2025-01-13. Review panel: Neurology.
| FDA submission number | K243950 |
|---|---|
| Pathway | 510(k) |
| Company | Kico Knee Innovation Company Pty Ltd |
| Review panel (specialty) | Neurology |
| FDA decision date | 2025-01-13 |
| Decision | Substantially Equivalent |
| Product code | SBF |
| Classification | Orthopedic Augmented Reality |
| Device class | 2 |
| Regulation number | 882.4560 |
| Review time (calendar days) | 21 |
| Applicant country | AU |
Official FDA database record · FDA AI-enabled device list
All Neurology AI devices · Full device index
Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.