GoLIF! Lumbar Interbody Fusion System is an AI-enabled medical device from GetSet Surgical, SA, listed by FDA (510(k), K250186) with a decision date of 2025-03-21. Review panel: Orthopedic.
| FDA submission number | K250186 |
|---|---|
| Pathway | 510(k) |
| Company | GetSet Surgical, SA |
| Review panel (specialty) | Orthopedic |
| FDA decision date | 2025-03-21 |
| Decision | Substantially Equivalent |
| Product code | MAX |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Device class | 2 |
| Regulation number | 888.3080 |
| Review time (calendar days) | 58 |
| Applicant country | CH |
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.