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 | K150321 |
| 510k Number | K150321 |
| 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 | John Souza |
| Correspondent | John Souza Cutting Edge Spine, LLC 101 Waxhaw Professional Park Drive, Suite A Waxhaw, NC 28173 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-02-09 |
| Decision Date | 2015-07-13 |
| Summary: | summary |