FDA Registration
Active
🇫🇷 France
NuVasive® RELINE System
Reg #: 1000461041
·
FEI: 1000461041
·
Expires 2025
Products
6
Proprietary Names
1
Establishment Types
1
Classifications
6
Registration Details
- Registration Name
- SELENIUM MEDICAL S.A.S.
- Registration Number
- 1000461041
- FEI Number
- 1000461041
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 9049 Rue de Quebec
- City
- La Rochelle Charente-Maritime
- Country
- FR
Regulatory Submissions
- 510(k) Number
- K143684
Owner / Operator
- Firm Name
- Selenium Medical S.A.S.
- Operator Number
- 10045214
- Address
- 9049 Rue de Quebec
- City
- La Rochelle
- State
- Charente-Maritime
- Postal Code
- 17000
- Country
- FR
US Agent
- Business Name
- DAWA MEDICAL LLC
- Contact Name
- Stephan TOUPIN
- Address
- 7320 NW, 12th street suite 103
- City
- Miami
- State
- FL
- ZIP
- 33126
- Country
- US
- [email protected]
- Phone
- 786 7311159
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2018-04-12 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2018-04-12 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2018-04-12 |
| Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | OSH | Class 2 | Orthopedic | No | 2018-04-12 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2018-04-12 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2018-04-12 |
Proprietary Names
NuVasive® RELINE System
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)