Waxhaw, NC, US · 6 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Class II | Orthopedic | 3 | 2020-05-13 |
| OUR | Sacroiliac Joint Fixation | Class II | Orthopedic | 2 | 2023-04-05 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | Class II | Orthopedic | 1 | 2025-03-12 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2025-03-12 | K250605 | EVOL® ha Hyper C Cervical Interbody Fusion System | ODP | Class II | Orthopedic |
| 2023-04-05 | K230689 | T-FIX 3DSI Joint Fusion System | OUR | Class II | Orthopedic |
| 2022-06-24 | K214123 | T-FIX® 3DSI Joint Fusion System | OUR | Class II | Orthopedic |
| 2020-05-13 | K200991 | EVOL Spinal Interbody System | MAX | Class II | Orthopedic |
| 2020-04-02 | K200552 | EVOS Lumbar Interbody System | MAX | Class II | Orthopedic |
| 2020-01-06 | K192497 | EVOL ha - D Lateral Interbody Fusion System | MAX | Class II | Orthopedic |