FDA Registration
Active
🇫🇷 France
LUMIS
Reg #: 3011221483
·
FEI: 3011221483
·
Expires 2025
Products
5
Proprietary Names
1
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- RESCOLL MANUFACTURING
- Registration Number
- 3011221483
- FEI Number
- 3011221483
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 4 Chemin du Solarium
- City
- Gradignan Nouvelle-Aquitaine
- Country
- FR
Regulatory Submissions
- 510(k) Number
- K112607
Owner / Operator
- Firm Name
- RESCOLL MANUFACTURING
- Operator Number
- 10047403
- Address
- 4 Chemin du solarium
- City
- GRADIGNAN
- State
- Nouvelle-Aquitaine
- Postal Code
- 33170
- Country
- FR
- Correspondent
- Patxi DRIEUX
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2015-11-04 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2015-11-04 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2015-11-04 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2015-11-04 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2015-11-04 |
Proprietary Names
LUMIS
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)