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 |