4WEB EU B.V.

FDA Device Registration & Listing · Assendelft Noord-Holland, NL · Registration 3011127597

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3011127597
FEI Number
3011127597
Entity Name
4WEB EU B.V.
City/State/Country
Assendelft Noord-Holland, NL
Establishment Address
Industrieweg 13b, Assendelft Noord-Holland 1566JN, NL
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device
Owner / Operator
4WEB, INC (Owner Number: 10037722)
Owner / Operator Contact Address
2801 Network Blvd., Suite 620, Frisco, TX 75034, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K173159
PMA Number
N/A

All Registered 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)

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2015-10-16
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2018-08-29
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2022-12-16
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2020-09-16
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2014-12-15
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2026-02-09
OUR Sacroiliac Joint Fixation Orthopedic Class 2 888.3040 2026-02-09
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2024-06-25
SAI Ankle Fusion Cage Orthopedic Class 2 888.3020 2024-06-25
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2019-10-03
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2022-12-16
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2016-03-01
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2024-06-25
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2016-11-05
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2025-05-02
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2025-05-02
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2022-12-16
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2023-01-26
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2023-07-17
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2018-08-29

Official Correspondent

Upasana Veturi

US Agent Details

John Oldham Business: 4WEB, INC Email: joldham@4webmedical.com Phone: (214) 9983892

Related Public Records

Same Entity

4WEB, INC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3009189869 4WEB INC. Frisco, TX, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K223430 Life Spine, Inc. ProLift Micro Expandable Spacer System 2023-05-04
K102293 Globus Medical, Inc. CALIBER SPACER 2011-01-05
K193541 Nu Vasive, Incorporated NuVasive Cohere Thoracolumbar Interbody System 2020-03-30
K080401 Advanced Medical Technologies AG SHELL CAGE, WAVE CAGE, LOOP CAGE 2008-05-09
K200084 Zavation Medical Products, LLC Zavation IBF System 2020-10-19

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0013-05 Biomet, Inc. 2
Lactosorb pin, 2.0 x 20 mm, sterile; ref. 948205.
Z-0034-2022 Flower Orthopedics Corporation 2
Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201
Z-0014-2014 Synthes USA HQ, Inc. 2
Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle.
Z-0026-2013 Orthohelix Surgical Designs Inc 2
OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0026-2016 Ortho Solutions Inc 330 Franklin Tnpk 2
Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West Station Business Park, Spital Road, Maldon, Essex CM96FF Rx Only a) Sterile b) Non-Sterile Orthopaedic Bone Screw

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011127597. Last updated year: 2026. Please use registration number 3011127597 when referencing this establishment in official correspondence.
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