The following data is part of a premarket notification filed by Vy Spine, Llc with the FDA for Univy Osteovy Cervical Ibf System.
| Device ID | K221162 |
| 510k Number | K221162 |
| Device Name: | UniVy OsteoVy Cervical IBF System |
| Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
| Applicant | Vy Spine, LLC 2236 Capital Circle NE, Suite 103-1 Tallahassee, FL 32308 |
| Contact | Jordan Hendrickson |
| Correspondent | Jordon Hendrickson Vy Spine, LLC 2236 Capital Circle NE, Suite 103-1 Tallahassee, FL 32308 |
| Product Code | ODP |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-04-22 |
| Decision Date | 2022-11-04 |