Irving, TX, US · 8 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Class II | Orthopedic | 3 | 2025-06-02 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | Class II | Orthopedic | 3 | 2025-04-22 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | Class II | Orthopedic | 1 | 2025-07-30 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | Class II | Orthopedic | 1 | 2023-12-01 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2025-07-30 | K251735 | Stabilis SA Cervical Stand-Alone System (Various PNs) | OVE | Class II | Orthopedic |
| 2025-06-02 | K251335 | Tera Lumbar Interbody Fusion System (Various PNs) | MAX | Class II | Orthopedic |
| 2025-04-22 | K243386 | Ventris Intervertebral Body Fusion Device | OVD | Class II | Orthopedic |
| 2024-07-17 | K241413 | sagAlign Lumbar Cage System (Various PNs) | MAX | Class II | Orthopedic |
| 2023-12-01 | K230639 | Align Cervical Interbody Fusion System | ODP | Class II | Orthopedic |
| 2022-09-23 | K222561 | Align | OVD | Class II | Orthopedic |
| 2022-07-22 | K221535 | Align Lumbar Interbody Fusion System | MAX | Class II | Orthopedic |
| 2021-05-04 | K201671 | A-Link Z | OVD | Class II | Orthopedic |