Vy Spine™ VyWasher™ Buttress System
Appliance, Fixation, Spinal Intervertebral Body
Vy Spine, LLC
The following data is part of a premarket notification filed by Vy Spine, Llc with the FDA for Vy Spine™ Vywasher™ Buttress System.
Pre-market Notification Details
| Device ID | K213219 |
| 510k Number | K213219 |
| Device Name: | Vy Spine™ VyWasher™ Buttress System |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | Vy Spine, LLC 2236 Capital Circle NE, Suite 103-1 Tallahassee, FL 32308 |
| Contact | Jordan Hendrickson |
| Correspondent | Jordan Hendrickson Vy Spine, LLC 2236 Capital Circle NE, Suite 103-1 Tallahassee, FL 32308 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-29 |
| Decision Date | 2021-12-23 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840283400629 | K213219 | 000 |
| 00840283400384 | K213219 | 000 |
| 00840283400377 | K213219 | 000 |
| 00840283400018 | K213219 | 000 |
| 00840283400001 | K213219 | 000 |
Trademark Results [Vy Spine]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 VY SPINE 90864368 not registered Live/Pending |
Vy Spine LLC 2021-08-04 |
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