FDA Registration
Active
🇺🇸 United States
SpheRx
Reg #: 3013491327
·
FEI: 3013491327
·
Expires 2025
Products
5
Proprietary Names
1
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- NuVasive Manufacturing, LLC
- Registration Number
- 3013491327
- FEI Number
- 3013491327
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 805 Liberty Lane
- City
- West Carrollton
- State
- OH
- ZIP
- 45449
- Country
- US
Regulatory Submissions
- 510(k) Number
- K082332
Owner / Operator
- Firm Name
- GLOBUS MEDICAL, INC.
- Operator Number
- 9056090
- Address
- 2560 GENERAL ARMISTEAD AVE., VALLEY FORGE BUSINESS CENTER
- City
- Audubon
- State
- PA
- Postal Code
- 19403
- Country
- US
- Correspondent
- DANIEL S PAUL
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2024-01-29 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2024-01-29 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2024-01-29 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2024-01-29 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2024-01-29 |
Proprietary Names
SpheRx
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)