FDA Registration
Active
🇳🇱 Netherlands
Posterior Spine Truss System
Reg #: 3011127597
·
FEI: 3011127597
·
Expires 2025
Products
1
Proprietary Names
4
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
- K143258
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 Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2015-10-16 |
Proprietary Names
Posterior Spine Truss System
OLIF Spine Truss System
TLIF Spine Truss System
PLIF Spine Truss System
Establishment Types
Export Device to the United States But Perform No Other Operation on Device