Yokneam Illit, IL · 6 510(k) clearances · 1 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| SBF | Orthopedic Augmented Reality | Class II | Neurology | 6 | 2026-07-31 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2025-04-14 | Class II | Ongoing | Z-1761-2025 | Augmedics Perc Pin Adaptor, Model/Catalog Number AMCH07200, a component of the xvision Spine (XVS) system, an image-guid… | — | The perc pin adaptor AMCH07200 tightening knob was found to be inconvenient to the user and the tightening markings found to be improperly placed. |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-07-31 | K261854 | xvision Spine system | SBF | Class II | Neurology |
| 2025-10-03 | K251639 | xvision Spine system | SBF | Class II | Neurology |
| 2025-03-13 | K250255 | xvision Spine system | SBF | Class II | Neurology |
| 2024-10-16 | K241481 | xvision Spine System | SBF | Class II | Neurology |
| 2022-11-17 | K220905 | xvision Spine System | SBF | Class II | Neurology |
| 2021-07-19 | K211188 | xvision Spine system (XVS) | SBF | Class II | Neurology |