FDA Registration
Active
🇺🇸 United States
VY SPINE, LLC
Reg #: 3019837678
·
FEI: 3019837678
·
Expires 2026
Products
15
Proprietary Names
22
Establishment Types
2
Classifications
15
Registration Details
- Registration Name
- VY SPINE, LLC
- Registration Number
- 3019837678
- FEI Number
- 3019837678
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 545 West 500 South, Suite 100 & 110
- City
- Bountiful
- State
- UT
- ZIP
- 84010
- Country
- US
Regulatory Submissions
- 510(k) Number
- K230414
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 Integrated Fixation, Cervical | OVE | Class 2 | Orthopedic | No | 2026-01-02 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2026-01-02 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2022-11-16 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2022-11-16 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2022-11-16 |
| Posterior Cervical Screw System | NKG | Class 2 | Orthopedic | No | 2026-01-02 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2022-11-16 |
| Orthosis, Spine, Plate, Laminoplasty, Metal | NQW | Class 2 | Orthopedic | No | 2026-01-02 |
| System, Facet Screw Spinal Device | MRW | Class U | Unknown | No | 2026-04-08 |
| Accessories, Fixation, Spinal Intervertebral Body | LYQ | Class 1 | Orthopedic | No | 2021-07-14 |
| Sacroiliac Joint Fixation | OUR | Class 2 | Orthopedic | No | 2026-01-02 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2026-03-02 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2026-03-02 |
| Spinal Vertebral Body Replacement Device | MQP | Class 2 | Orthopedic | No | 2026-01-02 |
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | Class 2 | Orthopedic | No | 2026-01-02 |
Proprietary Names
ClariVy NanoVy Ti Cervical IBF System
VyLinkTM Spinal Screw System
VyPlate Anterior Cervical Plate System
VySpan PCT System
LumiVy Lumbar IBF System
VyLam Laminoplasty System
Reliance Cervical IBF System - PEEK HA Enhanced
DiversiVy Facet Screw System
ClariVy
FortiVy OsteoVy Ti Lumbar IBF System
FortiVy OsteoVy Ti NanoVy HA Lumbar IBF System
ClariVy Cervical IBF System
VyLink Spinal Screw System
Reliance Spinal Screw System
Reliance Posterior Cervical Thoracic System
Reliance Cervical IBF System - Sterile, PEEK HA Enhanced
LumiVy NanoVy Ti Lumbar IBF System
UniVy OsteoVy Ti NanoVy HA Cervical IBF System
VyWasher Buttress System
LumiVy OsteoVy PEKK Lumbar IBF System
UniVy OsteoVy Cervical IBF System
ClariVy OsteoVy PEKK Cervical IBF System
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device