The following data is part of a premarket notification filed by Cutting Edge Spine, Llc with the FDA for Evol Spinal Interbody System, Evos Lumbar Interbody System.
| Device ID | K180891 |
| 510k Number | K180891 |
| Device Name: | EVOL Spinal Interbody System, 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 | 2018-04-05 |
| Decision Date | 2018-05-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841193120805 | K180891 | 000 |
| 00841193120799 | K180891 | 000 |
| 00841193120782 | K180891 | 000 |
| 00841193120775 | K180891 | 000 |
| 00841193120768 | K180891 | 000 |
| 00841193120751 | K180891 | 000 |
| 00841193120744 | K180891 | 000 |
| 00841193120737 | K180891 | 000 |
| 00841193120720 | K180891 | 000 |