FDA Registration
Active
🇩🇪 Germany
Coflex Interlaminar Technology
Reg #: 3005426761
·
FEI: 3005426761
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Paradigm Spine GmbH
- Registration Number
- 3005426761
- FEI Number
- 3005426761
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Eisenbahnstrabe 84
- City
- Wurmlingen Baden-Wurttemberg
- Country
- DE
Regulatory Submissions
- PMA Number
- P110008
Owner / Operator
- Firm Name
- Xtant Medical Holdings, Inc.
- Operator Number
- 10028385
- Address
- 664 Cruiser Lane
- City
- Belgrade
- State
- MT
- Postal Code
- 59714
- Country
- US
- Correspondent
- Rebecca Lennemann
US Agent
- Business Name
- Xtant Medical Holdings, Inc.
- Contact Name
- Rebecca Lennemann
- Address
- 664 Cruiser Lane
- City
- Belgrade
- State
- MT
- ZIP
- 59714
- Country
- US
- [email protected]
- Phone
- 406 9245878
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Spinous Process Spacer/Plate | NQO | Class 3 | Unknown | No | 2023-07-26 |
Proprietary Names
Coflex Interlaminar Technology
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility