FDA Registration
Active
🇨🇭 Switzerland
Perla TL
Reg #: 3007728266
·
FEI: 3007728266
·
Expires 2025
Products
6
Proprietary Names
1
Establishment Types
2
Classifications
6
Registration Details
- Registration Name
- SPINEART SA
- Registration Number
- 3007728266
- FEI Number
- 3007728266
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Chemin du Pre-Fleuri 3
- City
- Plan-les-Ouates Geneve
- Country
- CH
Regulatory Submissions
- 510(k) Number
- K193396
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, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2020-02-06 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2020-02-06 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2020-02-06 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2020-02-06 |
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | Class 2 | Orthopedic | No | 2020-02-06 |
| Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | OSH | Class 2 | Orthopedic | No | 2020-02-06 |
Proprietary Names
Perla TL
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility