Austin, TX, US · 4 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | Class II | Orthopedic | 2 | 2026-08-26 |
| OUR | Sacroiliac Joint Fixation | Class II | Orthopedic | 1 | 2025-07-09 |
| PEK | Spinous Process Plate | Class II | Orthopedic | 1 | 2023-08-15 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-08-26 | K262595 | VariLift-C Cervical Interbody Fusion System | ODP | Class II | Orthopedic |
| 2025-07-09 | K250247 | panaSIa SI Fusion System | OUR | Class II | Orthopedic |
| 2023-09-27 | K231076 | VariLift®-C Interbody Fusion System | ODP | Class II | Orthopedic |
| 2023-08-15 | K231807 | primaLOK SP Interspinous Fusion System | PEK | Class II | Orthopedic |