FDA Registration
Active
🇺🇸 United States
NEXUS SPINE, LLC.
Reg #: 3018210489
·
FEI: 3018210489
·
Expires 2026
Products
12
Proprietary Names
1
Establishment Types
2
Classifications
12
Registration Details
- Registration Name
- NEXUS SPINE, LLC.
- Registration Number
- 3018210489
- FEI Number
- 3018210489
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 13867 South Bangerter Parkway, Suite 150
- City
- Draper
- State
- UT
- ZIP
- 84020
- Country
- US
Regulatory Submissions
- 510(k) Number
- K231763
Owner / Operator
- Firm Name
- Nexus Spine, LLC.
- Operator Number
- 10048422
- Address
- 2825 E Cottonwood Parkway Suite 330
- City
- Salt Lake City
- State
- UT
- Postal Code
- 84121
- Country
- US
- Correspondent
- Jared Crocker
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Intervertebral Fusion Device With Integrated Fixation, Cervical | OVE | Class 2 | Orthopedic | No | 2023-08-29 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2023-12-04 |
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | Class 2 | Orthopedic | No | 2023-12-04 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2015-01-12 |
| Template | HWT | Class 1 | Orthopedic | No | 2017-05-09 |
| Rasp | HTR | Class 1 | General, Plastic Surgery | No | 2017-05-09 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2017-05-02 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2024-04-02 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2024-04-02 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2022-12-13 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2020-04-13 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2020-04-13 |
Proprietary Names
Nexus Spine
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198