Dallas, TX, US · 9 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | Class II | Orthopedic | 3 | 2026-07-22 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | Class II | Orthopedic | 3 | 2024-05-15 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Class II | Orthopedic | 2 | 2022-03-18 |
| OLO | Orthopedic Stereotaxic Instrument | Class II | Neurology | 1 | 2025-08-18 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-07-22 | K262094 | E3D-C Interbody System | OVE | Class II | Orthopedic |
| 2026-02-04 | K260038 | E3D-C Interbody System | OVE | Class II | Orthopedic |
| 2025-08-18 | K250167 | Evolution Spine Navigation Instruments | OLO | Class II | Neurology |
| 2024-08-12 | K241846 | E3D-C Interbody System | OVE | Class II | Orthopedic |
| 2024-05-15 | K240368 | E3D-A Interbody System | OVD | Class II | Orthopedic |
| 2024-01-30 | K232432 | E3D-A Interbody System | OVD | Class II | Orthopedic |
| 2023-02-07 | K223146 | EVOLUTION SPINE Interbody System | OVD | Class II | Orthopedic |
| 2022-03-18 | K220275 | EMERGE Anterior Cervical Plate System | KWQ | Class II | Orthopedic |
| 2021-09-30 | K212405 | EMERGE Anterior Cervical Plate System | KWQ | Class II | Orthopedic |