Veritas Reverse Total Shoulder System is an AI-enabled medical device from Restor3D, listed by FDA (510(k), K253992) with a decision date of 2026-05-07. Review panel: Orthopedic.
| FDA submission number | K253992 |
|---|---|
| Pathway | 510(k) |
| Company | Restor3D |
| Review panel (specialty) | Orthopedic |
| FDA decision date | 2026-05-07 |
| Decision | Substantially Equivalent |
| Product code | PHX |
| Classification | Shoulder Prosthesis, Reverse Configuration |
| Device class | 2 |
| Regulation number | 888.3660 |
| Review time (calendar days) | 146 |
| Applicant country | US |
Official FDA database record · FDA AI-enabled device list
All Orthopedic AI devices · Full device index
Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.