Austin, TX, US · 6 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | Class II | Orthopedic | 3 | 2025-02-07 |
| OUR | Sacroiliac Joint Fixation | Class II | Orthopedic | 1 | 2025-10-22 |
| OLO | Orthopedic Stereotaxic Instrument | Class II | Neurology | 1 | 2024-03-29 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Class II | Orthopedic | 1 | 2022-03-09 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2025-10-22 | K252322 | SIros-X System | OUR | Class II | Orthopedic |
| 2025-02-07 | K242483 | Genesys Spine AIS-C II Cervical Interbody Fusion System | OVE | Class II | Orthopedic |
| 2024-03-29 | K233595 | Genesys Spine Sacroiliac Joint Fusion System with Navigation | OLO | Class II | Neurology |
| 2023-12-13 | K233594 | Genesys Spine 3DP AIS-C II Cervical Interbody System | OVE | Class II | Orthopedic |
| 2022-03-09 | K220096 | Genesys Spine 3DP Lumbar Interbody System | MAX | Class II | Orthopedic |
| 2020-01-08 | K191489 | Genesys Spine 3DP Cervical Interbody System | OVE | Class II | Orthopedic |