FDA Registration
Active
🇳🇱 Netherlands
4WEB EU B.V.
Reg #: 3011127597
·
FEI: 3011127597
·
Expires 2026
Products
11
Proprietary Names
45
Establishment Types
1
Classifications
11
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Registration Details
- Registration Name
- 4WEB EU B.V.
- Registration Number
- 3011127597
- FEI Number
- 3011127597
- Status
- Active
- Expiry Year
- 2026
- 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
- Upasana Y Veturi
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 |
| Pin, Fixation, Smooth | HTY | Class 2 | Orthopedic | No | 2022-12-16 |
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | Class 2 | Orthopedic | No | 2020-09-16 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2014-12-15 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2026-02-09 |
| Sacroiliac Joint Fixation | OUR | Class 2 | Orthopedic | No | 2026-02-09 |
| Rod, Fixation, Intramedullary And Accessories | HSB | Class 2 | Orthopedic | No | 2024-06-25 |
| Ankle Fusion Cage | SAI | Class 2 | Orthopedic | No | 2024-06-25 |
| Intervertebral Fusion Device With Integrated Fixation, Cervical | OVE | Class 2 | Orthopedic | No | 2019-10-03 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2022-12-16 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2025-05-02 |
Proprietary Names
PLIF Spine Truss System
Posterior Spine Truss System
OLIF Spine Truss System
TLIF Spine Truss System
Posterior Spine Truss System (PSTS)
Posterior Spine Truss System (PSTS) Interbody Fusion Device
Hammertoe Truss System (HTS)
Anterior Spine Truss System - Stand Alone (ASTS-SA) Interbody Fusion Device
4WEB Osteotomy Wedge
Osteotomy Truss System
Sacroiliac Joint Truss System (SJTS)
Ankle Truss System (ATS)
Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device
Cervical Spine Truss System Plating Solution (CSTS-PS)
ALIF Spine Truss System
ALIF Spine Truss System Interbody Fusion Device
Anterior Spine Truss System - Stand Alone (ASTS-SA)
Lateral STS
Lateral Spine Truss System
intervertebral fusion device with bone graft, cervical - Cervical Spine Truss System (CSTS)
Intervertebral fusion device with integrated fixation, cervical - Cervical Spine Truss System (CSTS)
Osteotomy Truss System (OTS)
Cervical Spine Truss System (CSTS) Interbody Fusion Device 2
CERVICAL SPINE TRUSS SYSTEM - STAND ALONE (CSTS-SA) INTERBODY FUSION DEVICE
Cervical Spine Truss System (CSTS) Interbody Fusion Device
Cervical Spine Truss System (CSTS)
Sterile Packaged Osteotomy Truss System
Sterile Packaged Posterior Spine Truss System
Sterile Packaged Cervical Spine Truss System
Sterile Packaged ALIF Spine Truss System
Intervertebral fusion device with bone graft, lumbar
Intervertebral fusion device with integrated fixation, lumbar
Lateral Spine Truss System (LSTS)
ALIF Spinal Truss System
ALIF STS
4-Web ALIF STS
4-Web STS
4-Web Spinal Truss System
4-Web ALIF Spinal Truss System
Cervical Spine Truss System - Stand Alone (CSTS-SA)
Anterior Spine Truss System (ASTS) Interbody Fusion Device
Anterior Spine Truss System (ASTS)
Anterior Spine Truss System (STS) Interbody Fusion Device
Lumbar Spine Truss System Plating Solution (LSTS-PS)
Lateral Spine Truss System (LSTS) Interbody Fusion Device
Establishment Types
Export Device to the United States But Perform No Other Operation on Device