The following data is part of a premarket notification filed by Cutting Edge Spine, Llc with the FDA for Evos Lumbar Interbody System.
| Device ID | K200552 |
| 510k Number | K200552 |
| Device Name: | EVOS Lumbar Interbody System |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | Cutting Edge Spine, LLC 101 Waxhaw Professional Park, Suite A Waxhaw, NC 28173 |
| Contact | Kyle Kuntz |
| Correspondent | Kyle Kuntz Cutting Edge Spine, LLC 101 Waxhaw Professional Park, Suite A Waxhaw, NC 28173 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-03 |
| Decision Date | 2020-04-02 |