FDA Registration
Active
🇺🇸 United States
UniVy OsteoVy Cervical IBF System
Reg #: 3019837678
·
FEI: 3019837678
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- VY SPINE, LLC
- Registration Number
- 3019837678
- FEI Number
- 3019837678
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 545 West 500 South, Suite 100 & 110
- City
- Bountiful
- State
- UT
- ZIP
- 84010
- Country
- US
Regulatory Submissions
- 510(k) Number
- K221162
Owner / Operator
- Firm Name
- Vy Spine, LLC
- Operator Number
- 10082347
- Address
- 545 West 500 South #110
- City
- Bountiful
- State
- UT
- Postal Code
- 84010
- Country
- US
- Correspondent
- Jordan Hendrickson
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2022-11-16 |
Proprietary Names
UniVy OsteoVy Cervical IBF System
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device