FDA Registration
Active
🇳🇱 Netherlands
Anterior Spine Truss System - Stand Alone (ASTS-SA) Interbody Fusion Device
Reg #: 3011127597
·
FEI: 3011127597
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- 4WEB EU B.V.
- Registration Number
- 3011127597
- FEI Number
- 3011127597
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Industrieweg 13b
- City
- Assendelft Noord-Holland
- Country
- NL
Regulatory Submissions
- 510(k) Number
- K200002
Owner / Operator
- Firm Name
- 4WEB, INC
- Operator Number
- 10037722
- Address
- 2801 Network Blvd., Suite 620
- City
- Frisco
- State
- TX
- Postal Code
- 75034
- Country
- US
- Correspondent
- John J Oldham
US Agent
- Business Name
- 4WEB, INC
- Contact Name
- John Oldham
- Address
- 2801 Network Blvd Suite 620
- City
- Frisco
- State
- TX
- ZIP
- 75034
- Country
- US
- [email protected]
- Phone
- 214 9983892
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | Class 2 | Orthopedic | No | 2020-09-16 |
Proprietary Names
Anterior Spine Truss System - Stand Alone (ASTS-SA) Interbody Fusion Device
Establishment Types
Export Device to the United States But Perform No Other Operation on Device