| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| NKB | Thoracolumbosacral Pedicle Screw System | Class II | Orthopedic | 2 | 2023-06-15 |
| BSO | Catheter, Conduction, Anesthetic | Class II | Anesthesiology | 1 | 2025-02-13 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | Class II | Orthopedic | 1 | 2021-09-13 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2025-02-13 | K241410 | EDEN ControlCath | BSO | Class II | Anesthesiology |
| 2023-06-15 | K230762 | EDEN Spinal Fixation MIS System | NKB | Class II | Orthopedic |
| 2022-06-23 | K201788 | EDEN Spinal Fixation System | NKB | Class II | Orthopedic |
| 2021-09-13 | K201793 | EDEN Peek Cage | ODP | Class II | Orthopedic |