Cheongju-Si, KR · 10 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | Class II | Orthopedic | 2 | 2024-08-20 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | Class II | Orthopedic | 2 | 2023-07-20 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Class II | Orthopedic | 2 | 2023-04-26 |
| NKG | Posterior Cervical Screw System | Class II | Orthopedic | 1 | 2026-09-17 |
| OLO | Orthopedic Stereotaxic Instrument | Class II | Neurology | 1 | 2024-12-06 |
| NKB | Thoracolumbosacral Pedicle Screw System | Class II | Orthopedic | 1 | 2024-04-03 |
| NDN | Cement, Bone, Vertebroplasty | Class II | Orthopedic | 1 | 2021-10-28 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-09-17 | K254260 | The VEGA Cervical Screw System | NKG | Class II | Orthopedic |
| 2024-12-06 | K243073 | AnyPlus Navigated Instruments System | OLO | Class II | Neurology |
| 2024-08-20 | K241738 | PYXIS 3D Titanium Cervical Cage system | ODP | Class II | Orthopedic |
| 2024-04-03 | K240350 | AnyPlus II Spinal Fixation System | NKB | Class II | Orthopedic |
| 2023-07-20 | K231808 | QUASAR Standalone ACIF System | OVE | Class II | Orthopedic |
| 2023-04-26 | K223868 | PYXIS 3D Titanium Cage System | MAX | Class II | Orthopedic |
| 2023-02-09 | K222041 | CYGNUS-C Standalone ACIF System | OVE | Class II | Orthopedic |
| 2022-07-27 | K221687 | Pegasus-X Expandable PLIF System | MAX | Class II | Orthopedic |
| 2021-10-28 | K211797 | TRACKER Plus Kyphoplasty System | NDN | Class II | Orthopedic |
| 2020-08-10 | K200592 | GS Medical AnyPlus PEEK Cage System | ODP | Class II | Orthopedic |