FDA Registration
Active
🇫🇷 France
Universal Tendon Spacer
Reg #: 3008880500
·
FEI: 3008880500
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ASKORN MEDICAL
- Registration Number
- 3008880500
- FEI Number
- 3008880500
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 44c rue de Bray
- City
- Cesson Sevigne Bretagne
- Country
- FR
Regulatory Submissions
- 510(k) Number
- K243477
Owner / Operator
- Firm Name
- Askorn Medical
- Operator Number
- 10044425
- Address
- 44c rue de Bray
- City
- Cesson Sevigne
- State
- Bretagne
- Postal Code
- F-35510
- Country
- FR
US Agent
- Business Name
- Registrar Corp
- Contact Name
- David Lennarz
- Address
- 144 Research Drive
- City
- Hampton
- State
- VA
- ZIP
- 23666
- Country
- US
- [email protected]
- Phone
- 757 2240177
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Tendon, Passive | HXA | Class 2 | Orthopedic | No | 2025-04-02 |
Proprietary Names
Universal Tendon Spacer
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility