FDA Registration
Active
🇫🇷 France
ROMEO
Reg #: 3010658151
·
FEI: 3010658151
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
2
Classifications
3
Registration Details
- Registration Name
- Alpes CN
- Registration Number
- 3010658151
- FEI Number
- 3010658151
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Immeuble ABC3, 80 rue Douglas Engelbart,, Archamps Technopole,
- City
- Archamps Haute-Savoie
- Country
- FR
Regulatory Submissions
- 510(k) Number
- K093936
Owner / Operator
- Firm Name
- SPINEART SA
- Operator Number
- 10028947
- Address
- Chemin du Pre-Fleuri 3
- City
- Plan-les-Ouates
- State
- Geneve
- Postal Code
- 1228
- Country
- CH
- Correspondent
- Max LOK
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2010-03-23 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2010-03-23 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2010-03-23 |
Proprietary Names
ROMEO
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device