The following data is part of a premarket notification filed by Vy Spine, Llc with the FDA for Vy Spine™ Vyspan™ Pct System.
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 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
VY SPINE 90864368 not registered Live/Pending |
Vy Spine LLC 2021-08-04 |