| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Class II | Orthopedic | 2 | 2025-01-14 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Class II | Orthopedic | 2 | 2024-12-31 |
| NKB | Thoracolumbosacral Pedicle Screw System | Class II | Orthopedic | 2 | 2024-07-24 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | Class II | Orthopedic | 1 | 2024-03-22 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2025-01-14 | K243904 | Elegance® Anterior Cervical plate | KWQ | Class II | Orthopedic |
| 2024-12-31 | K243670 | Idys® LIF | MAX | Class II | Orthopedic |
| 2024-07-24 | K241863 | Erisma® Lp Spinal Fixation System; Erisma® LP MIS | NKB | Class II | Orthopedic |
| 2024-04-26 | K240872 | Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation System | NKB | Class II | Orthopedic |
| 2024-03-22 | K240715 | Idys® C ZP 3DTi | OVE | Class II | Orthopedic |
| 2022-03-30 | K220182 | Aggeris-C | KWQ | Class II | Orthopedic |
| 2021-04-12 | K200919 | Idys ALIF 3DTi | MAX | Class II | Orthopedic |