FDA Registration
Active
🇫🇷 France
COMPANION SPINE
Reg #: 3025435185
·
FEI: 3025435185
·
Expires 2026
Products
4
Proprietary Names
5
Establishment Types
2
Classifications
4
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Registration Details
- Registration Name
- COMPANION SPINE
- Registration Number
- 3025435185
- FEI Number
- 3025435185
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Immeuble le Bridge - 5 Allee des Acacias
- City
- Merignac Gironde
- Country
- FR
Regulatory Submissions
- 510(k) Number
- K201704
- PMA Number
- P110008
Owner / Operator
- Firm Name
- Companion Spine
- Operator Number
- 10086759
- Address
- Immeuble le Bridge - 5 Allee des Acacias
- City
- Mérignac
- State
- Gironde
- Postal Code
- 33700
- Country
- FR
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Spinous Process Spacer/Plate | NQO | Class 3 | Unknown | No | 2025-12-04 |
| Spinous Process Plate | PEK | Class 2 | Orthopedic | No | 2025-12-04 |
| Manual Instruments Designed For Use With Non-Fusion Spinous Process Spacer Devices | QLR | Class 2 | Orthopedic | No | 2025-12-17 |
| Prosthesis, Intervertebral Disc | MJO | Class 3 | Unknown | No | 2022-12-08 |
Proprietary Names
Coflex Interlaminar Technology
Cofix System
Companion Spine DIAM Instrumentation
DIAM Spinal Stabilization System
Bryan Cervical Disc Prosthesis
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility