Beijing, CN · 4 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| HRX | Arthroscope | Class II | Orthopedic | 1 | 2026-08-28 |
| HSB | Rod, Fixation, Intramedullary And Accessories | Class II | Orthopedic | 1 | 2026-06-17 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Class II | Orthopedic | 1 | 2026-06-15 |
| NKB | Thoracolumbosacral Pedicle Screw System | Class II | Orthopedic | 1 | 2025-10-24 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-08-28 | K260203 | Fule Vertebroplasty Balloon Catheter | HRX | Class II | Orthopedic |
| 2026-06-17 | K253155 | Fule Metallic Lockable Intramedullary Nail Systems | HSB | Class II | Orthopedic |
| 2026-06-15 | K253151 | Fule Interbody Fusion Cage System | MAX | Class II | Orthopedic |
| 2025-10-24 | K252730 | Fule Spinal Fixation System | NKB | Class II | Orthopedic |