FDA Registration
Active
🇺🇸 United States
GSO GS1 Cannulated Screw System
Reg #: 3006215390
·
FEI: 3006215390
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
2
Classifications
3
Registration Details
- Registration Name
- Unified Spine, LLC
- Registration Number
- 3006215390
- FEI Number
- 3006215390
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 6295 Maxtown Road, Suite #500
- City
- Westerville
- State
- OH
- ZIP
- 43082
- Country
- US
Regulatory Submissions
- 510(k) Number
- K123487
Owner / Operator
- Firm Name
- Unified Spine, LLC
- Operator Number
- 10083837
- Address
- 6295 Maxtown Road, Suite #500
- City
- Westerville
- State
- OH
- Postal Code
- 43082
- Country
- US
- Correspondent
- Scott Smith
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2021-12-22 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2021-12-22 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2021-12-22 |
Proprietary Names
GSO GS1 Cannulated Screw System
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device