Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K190025
EVOL® -SI Joint Fusion System · Cutting Edge Spine, LLC · decided 2019-08-12 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| EVOL®SI Joint Fusion System | 5006-040T | Cutting Edge Spine, LLC | OUR | 00841193122915 |
| EVOL®SI Joint Fusion System | CES-311 | Cutting Edge Spine, LLC | OUR | 00841193125107 |
| EVOL®SI Joint Fusion System | 5005-050T-32 | Cutting Edge Spine, LLC | OUR | 00841193124872 |
| EVOL®SI Joint Fusion System | 5005-WT | Cutting Edge Spine, LLC | OUR | 00841193122984 |
| EVOL®SI Joint Fusion System | 5005-030T | Cutting Edge Spine, LLC | OUR | 00841193122816 |
| EVOL®SI Joint Fusion System | 5006-045T | Cutting Edge Spine, LLC | OUR | 00841193122922 |
| EVOL®SI Joint Fusion System | 5006-025T | Cutting Edge Spine, LLC | OUR | 00841193122885 |
| EVOL®SI Joint Fusion System | 5006-060T-32 | Cutting Edge Spine, LLC | OUR | 00841193124971 |
| EVOL®SI Joint Fusion System | 5006-045T-32 | Cutting Edge Spine, LLC | OUR | 00841193124940 |
| EVOL®SI Joint Fusion System | 5004-035T | Cutting Edge Spine, LLC | OUR | 00841193122748 |
| EVOL®SI Joint Fusion System | 5005-040T-32 | Cutting Edge Spine, LLC | OUR | 00841193112237 |
| EVOL®SI Joint Fusion System | 5005-060T | Cutting Edge Spine, LLC | OUR | 00841193122878 |
| EVOL®SI Joint Fusion System | 5006-030T | Cutting Edge Spine, LLC | OUR | 00841193122892 |
| EVOL®SI Joint Fusion System | 5004-040T | Cutting Edge Spine, LLC | OUR | 00841193122755 |
| EVOL®SI Joint Fusion System | 5005-050T | Cutting Edge Spine, LLC | OUR | 00841193122854 |
| EVOL®SI Joint Fusion System | 5004-045T | Cutting Edge Spine, LLC | OUR | 00841193122762 |
| EVOL®SI Joint Fusion System | 5004-025T | Cutting Edge Spine, LLC | OUR | 00841193122724 |
| EVOL®SI Joint Fusion System | 5004-055T | Cutting Edge Spine, LLC | OUR | 00841193122786 |
| EVOL®SI Joint Fusion System | 5002-045T | Cutting Edge Spine, LLC | OUR | 00841193122687 |
| EVOL®SI Joint Fusion System | 5006-035T-32 | Cutting Edge Spine, LLC | OUR | 00841193124926 |
| EVOL®SI Joint Fusion System | 5002-050T | Cutting Edge Spine, LLC | OUR | 00841193122694 |
| EVOL®SI Joint Fusion System | 5002-060T | Cutting Edge Spine, LLC | OUR | 00841193122717 |
| EVOL®SI Joint Fusion System | 5005-045T | Cutting Edge Spine, LLC | OUR | 00841193122847 |
| EVOL®SI Joint Fusion System | 5006-060T | Cutting Edge Spine, LLC | OUR | 00841193122953 |
| EVOL®SI Joint Fusion System | 5006-025T-32 | Cutting Edge Spine, LLC | OUR | 00841193124902 |