Quebec, CA · 12 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| HRS | Plate, Fixation, Bone | Class II | Orthopedic | 6 | 2025-10-28 |
| PBF | Orthopaedic Surgical Planning And Instrument Guides | Class II | Orthopedic | 3 | 2025-10-21 |
| HSX | Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | Class II | Orthopedic | 3 | 2021-10-12 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2025-10-28 | K253300 | Fine Osteotomy | HRS | Class II | Orthopedic |
| 2025-10-21 | K250394 | Fine TTO | PBF | Class II | Orthopedic |
| 2025-08-21 | K250923 | Fine Osteotomy | HRS | Class II | Orthopedic |
| 2024-09-05 | K241356 | Fine Osteotomy | HRS | Class II | Orthopedic |
| 2024-04-12 | K240703 | Fine Osteotomy | HRS | Class II | Orthopedic |
| 2024-02-09 | K240066 | Fine Osteotomy | PBF | Class II | Orthopedic |
| 2023-06-02 | K231314 | Fine Osteotomy | PBF | Class II | Orthopedic |
| 2021-10-12 | K212307 | BC Reflex Uni Knee System | HSX | Class II | Orthopedic |
| 2021-08-20 | K211895 | BC Reflex Uni Knee System | HSX | Class II | Orthopedic |
| 2021-07-28 | K211646 | FINE Osteotomy | HRS | Class II | Orthopedic |
| 2021-03-12 | K203697 | BC Reflex Uni Knee System | HSX | Class II | Orthopedic |
| 2020-03-25 | K193614 | FINE Osteotomy around the knee | HRS | Class II | Orthopedic |