EVOL Spinal Interbody System
Intervertebral Fusion Device With Bone Graft, Lumbar
Cutting Edge Spine, LLC
The following data is part of a premarket notification filed by Cutting Edge Spine, Llc with the FDA for Evol Spinal Interbody System.
Pre-market Notification Details
| Device ID | K200991 |
| 510k Number | K200991 |
| Device Name: | EVOL Spinal 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 | 2020-04-15 |
| Decision Date | 2020-05-13 |
Trademark Results [EVOL Spinal Interbody System]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 EVOL SPINAL INTERBODY SYSTEM 86928519 5220960 Live/Registered |
Cutting Edge Spine, LLC 2016-03-03 |
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