Vy Spine™ VySpan™ PCT System
Posterior Cervical Screw System
Vy Spine, LLC
The following data is part of a premarket notification filed by Vy Spine, Llc with the FDA for Vy Spine™ Vyspan™ Pct System.
Pre-market Notification Details
| Device ID | K213394 |
| 510k Number | K213394 |
| Device Name: | Vy Spine™ VySpan™ PCT System |
| Classification | Posterior Cervical Screw System |
| 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 | NKG |
| CFR Regulation Number | 888.3075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-10-15 |
| Decision Date | 2021-12-10 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840283400803 | K213394 | 000 |
| 00840283400513 | K213394 | 000 |
| 00840283400520 | K213394 | 000 |
| 00840283400537 | K213394 | 000 |
| 00840283400544 | K213394 | 000 |
| 00840283400551 | K213394 | 000 |
| 00840283400568 | K213394 | 000 |
| 00840283400575 | K213394 | 000 |
| 00840283400582 | K213394 | 000 |
| 00840283400506 | K213394 | 000 |
| 00840283400490 | K213394 | 000 |
| 00840283400414 | K213394 | 000 |
| 00840283400421 | K213394 | 000 |
| 00840283400438 | K213394 | 000 |
| 00840283400445 | K213394 | 000 |
| 00840283400452 | K213394 | 000 |
| 00840283400469 | K213394 | 000 |
| 00840283400476 | K213394 | 000 |
| 00840283400483 | K213394 | 000 |
| 00840283400599 | K213394 | 000 |
| 00840283400605 | K213394 | 000 |
| 00840283400728 | K213394 | 000 |
| 00840283400735 | K213394 | 000 |
| 00840283400742 | K213394 | 000 |
| 00840283400759 | K213394 | 000 |
| 00840283400766 | K213394 | 000 |
| 00840283400773 | K213394 | 000 |
| 00840283400780 | K213394 | 000 |
| 00840283400797 | K213394 | 000 |
| 00840283400711 | K213394 | 000 |
| 00840283400704 | K213394 | 000 |
| 00840283400612 | K213394 | 000 |
| 00840283400636 | K213394 | 000 |
| 00840283400643 | K213394 | 000 |
| 00840283400650 | K213394 | 000 |
| 00840283400667 | K213394 | 000 |
| 00840283400674 | K213394 | 000 |
| 00840283400681 | K213394 | 000 |
| 00840283400698 | K213394 | 000 |
| 00840283400407 | K213394 | 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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