Carlsbad, CA, US · 6 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| MRW | System, Facet Screw Spinal Device | Unclassified | Unknown | 1 | 2025-03-24 |
| OUR | Sacroiliac Joint Fixation | Class II | Orthopedic | 1 | 2022-10-03 |
| PEK | Spinous Process Plate | Class II | Orthopedic | 1 | 2022-07-08 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | Class II | Orthopedic | 1 | 2022-05-27 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | Class II | Orthopedic | 1 | 2021-08-02 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Class II | Orthopedic | 1 | 2021-03-23 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2025-03-24 | K243865 | AERO MIS Facet Fusion System | MRW | Unclassified | Unknown |
| 2022-10-03 | K221047 | SILO TFX MIS Sacroiliac Joint Fixation System | OUR | Class II | Orthopedic |
| 2022-07-08 | K221399 | ZIP MIS Interspinous Fusion System | PEK | Class II | Orthopedic |
| 2022-05-27 | K220610 | SOLO-L | OVD | Class II | Orthopedic |
| 2021-08-02 | K210521 | DEXA-C Cervical Interbody System | ODP | Class II | Orthopedic |
| 2021-03-23 | K210325 | APOLLO Anterior Cervical Plate (ACP) System | KWQ | Class II | Orthopedic |