Xiamen, CN · 9 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| HWC | Screw, Fixation, Bone | Class II | Orthopedic | 3 | 2024-12-04 |
| HRS | Plate, Fixation, Bone | Class II | Orthopedic | 2 | 2023-01-25 |
| NKB | Thoracolumbosacral Pedicle Screw System | Class II | Orthopedic | 1 | 2025-11-18 |
| NKG | Posterior Cervical Screw System | Class II | Orthopedic | 1 | 2023-11-22 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Class II | Orthopedic | 1 | 2023-03-14 |
| HSB | Rod, Fixation, Intramedullary And Accessories | Class II | Orthopedic | 1 | 2022-12-21 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2025-11-18 | K252729 | Universal Spinal System | NKB | Class II | Orthopedic |
| 2024-12-04 | K242348 | Locking Screw,CoCrMo | HWC | Class II | Orthopedic |
| 2023-11-22 | K233078 | Posterior Cervical Spine System | NKG | Class II | Orthopedic |
| 2023-03-14 | K223753 | Cervical Plate System | KWQ | Class II | Orthopedic |
| 2023-01-25 | K221150 | Advanced Bone Plate | HRS | Class II | Orthopedic |
| 2023-01-18 | K221088 | Anatomic Bone Plate | HRS | Class II | Orthopedic |
| 2023-01-10 | K221090 | Metal Cannulated Screw | HWC | Class II | Orthopedic |
| 2022-12-21 | K221221 | Advanced Intramedullary Nail System | HSB | Class II | Orthopedic |
| 2022-12-12 | K220921 | Metal Bone Screw | HWC | Class II | Orthopedic |