Cutting Edge Spine, LLC
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 11
- Inspections
- 2
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K250605 | EVOL® ha Hyper C Cervical Interbody Fusion System | March 12, 2025 |
| K230689 | T-FIX 3DSI Joint Fusion System | April 5, 2023 |
| K214123 | T-FIX® 3DSI Joint Fusion System | June 24, 2022 |
| K200991 | EVOL Spinal Interbody System | May 13, 2020 |
| K200552 | EVOS Lumbar Interbody System | April 2, 2020 |
| K192497 | EVOL ha - D Lateral Interbody Fusion System | January 6, 2020 |
| K190025 | EVOL® -SI Joint Fusion System | August 12, 2019 |
| K180674 | EVOL® ha-C Cervical Interbody Fusion System | June 25, 2018 |
| K180891 | EVOL Spinal Interbody System, EVOS Lumbar Interbody System | May 4, 2018 |
| K150321 | EVOS Lumbar Interbody System | July 13, 2015 |
| K102957 | CUTTING EDGE SPINE INTERBODY FUSION DEVICE | April 28, 2011 |