Seoul, KR · 19 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| HRS | Plate, Fixation, Bone | Class II | Orthopedic | 9 | 2025-05-30 |
| HSB | Rod, Fixation, Intramedullary And Accessories | Class II | Orthopedic | 2 | 2025-12-10 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | Class II | Orthopedic | 2 | 2025-02-18 |
| JEY | Plate, Bone | Class II | Dental | 1 | 2026-04-02 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | Class II | Orthopedic | 1 | 2025-06-27 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Class II | Orthopedic | 1 | 2025-06-12 |
| NKB | Thoracolumbosacral Pedicle Screw System | Class II | Orthopedic | 1 | 2024-11-08 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Class II | Orthopedic | 1 | 2024-07-24 |
| HWC | Screw, Fixation, Bone | Class II | Orthopedic | 1 | 2024-03-11 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-04-02 | K252246 | Leforte MMF System | JEY | Class II | Dental |
| 2025-12-10 | K252826 | ARIX Femur Nail System | HSB | Class II | Orthopedic |
| 2025-06-27 | K251431 | FIX-C PEEK ACIF SA System | OVE | Class II | Orthopedic |
| 2025-06-12 | K243973 | FIX-L PEEK PLIF and T-PLIF System | MAX | Class II | Orthopedic |
| 2025-05-30 | K242751 | ARIX Pectus Bar System | HRS | Class II | Orthopedic |
| 2025-04-22 | K242247 | ARIX Femur Nail System | HSB | Class II | Orthopedic |
| 2025-02-18 | K243915 | FIX-C 3D Ti ACIF System | ODP | Class II | Orthopedic |
| 2024-11-08 | K243004 | Xpine Spinal Fixation System | NKB | Class II | Orthopedic |
| 2024-07-24 | K231251 | FlexWing Anterior Cervical Plate System | KWQ | Class II | Orthopedic |
| 2024-03-11 | K233912 | ARIX Cannulated Screw System | HWC | Class II | Orthopedic |
| 2023-12-14 | K231887 | ARIX Ankle Distal Tibia System | HRS | Class II | Orthopedic |
| 2023-07-17 | K231441 | ARIX Ankle System | HRS | Class II | Orthopedic |
| 2023-05-03 | K230938 | ARIX Humerus System | HRS | Class II | Orthopedic |
| 2022-11-22 | K221412 | ARIX Rib System | HRS | Class II | Orthopedic |
| 2022-08-24 | K221920 | ARIX Small Fragment System | HRS | Class II | Orthopedic |
| 2021-12-21 | K212266 | FIX-C PEEK Anterior Cervical Interbody System | ODP | Class II | Orthopedic |
| 2020-10-29 | K202912 | ARIX Ankle Distal Tibia System | HRS | Class II | Orthopedic |
| 2020-09-15 | K201656 | ARIX Elbow System | HRS | Class II | Orthopedic |
| 2020-03-04 | K193616 | ARIX Ankle System | HRS | Class II | Orthopedic |