Montreal, CA · 8 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| OLO | Orthopedic Stereotaxic Instrument | Class II | Neurology | 3 | 2024-02-21 |
| SBF | Orthopedic Augmented Reality | Class II | Neurology | 2 | 2023-06-13 |
| QHE | — | — | — | 2 | 2021-10-12 |
| LLZ | System, Image Processing, Radiological | Class II | Radiology | 1 | 2023-05-23 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2024-02-21 | K233199 | ROSA® Shoulder System | OLO | Class II | Neurology |
| 2023-06-13 | K230567 | OptiVu ROSA® MxR | SBF | Class II | Neurology |
| 2023-05-23 | K231162 | ROSA Hip System | LLZ | Class II | Radiology |
| 2023-02-22 | K230180 | Rosa Knee System | OLO | Class II | Neurology |
| 2022-07-29 | K220733 | OptiVu ROSA MxR | SBF | Class II | Neurology |
| 2022-04-22 | K213708 | ROSA® Knee System | OLO | Class II | Neurology |
| 2021-10-12 | K212560 | Signature ONE System | QHE | — | — |
| 2020-06-05 | K200615 | Signature ONE System | QHE | — | — |