Data / Medical devices / Netherlands / 4web Eu B.V.
4web Eu B.V.: FDA-registered device maker in Assendelft Noord-Holland, Netherlands, 26 510(k) clearances
4web Eu B.V. is registered with the FDA (registration 3011127597) in Assendelft Noord-Holland, Netherlands. It lists 11 device types. The FDA files 26 510(k) clearances under its listings, the newest dated January 28, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3011127597
- Address
- Industrieweg 13b, Assendelft Noord-Holland, Netherlands, 1566JN
- Owner or operator
- 4WEB, INC (10037722)
- Roles
- Exporter to the US
- First device listed
- August 10, 2011
- Registered through
- 2026
- Brand names listed
- 4-Web ALIF STS, 4-Web ALIF Spinal Truss System, 4-Web STS, 4-Web Spinal Truss System, 4WEB Osteotomy Wedge, ALIF STS, ALIF Spinal Truss System, ALIF Spine Truss System and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Ankle Fusion Cage | SAI | 2 | Exporter to the US | accessdata.fda.gov |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | 2 | Exporter to the US | accessdata.fda.gov |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | 2 | Exporter to the US | accessdata.fda.gov |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | 2 | Exporter to the US | accessdata.fda.gov |
| Intervertebral Fusion Device With Integrated Fixation, Cervical | OVE | 2 | Exporter to the US | accessdata.fda.gov |
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | 2 | Exporter to the US | accessdata.fda.gov |
| Pin, Fixation, Smooth | HTY | 2 | Exporter to the US | accessdata.fda.gov |
| Plate, Fixation, Bone | HRS | 2 | Exporter to the US | accessdata.fda.gov |
| Rod, Fixation, Intramedullary And Accessories | HSB | 2 | Exporter to the US | accessdata.fda.gov |
| Sacroiliac Joint Fixation | OUR | 2 | Exporter to the US | accessdata.fda.gov |
| Screw, Fixation, Bone | HWC | 2 | Exporter to the US | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 28, 2026 | K252834 | Sacroiliac Joint Truss System (SJTS) | OUR | Substantially Equivalent | 4Web Medical | accessdata.fda.gov |
| December 11, 2025 | K253200 | Cervical Spine Truss System - Stand Alone (CSTS-SA) | OVE | Substantially Equivalent | 4Web Medical, Inc. | accessdata.fda.gov |
| April 25, 2025 | K251117 | Cervical Spine Truss System (CSTS) | OVE | Substantially Equivalent | 4Web Medical | accessdata.fda.gov |
| April 22, 2024 | K233966 | Anterior Spine Truss System-Stand Alone (ASTS-SA) | OVD | Substantially Equivalent | 4Web Medical, Inc. | accessdata.fda.gov |
| March 21, 2024 | K230088 | Ankle Truss System (ATS) | SAI | Substantially Equivalent | 4Web Medical, Inc. | accessdata.fda.gov |
| September 25, 2023 | K231739 | Cervical Spine Truss System (CSTS) | OVE | Substantially Equivalent | 4Web Medical, Inc. | accessdata.fda.gov |
| February 2, 2023 | K223362 | Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device | OVE | Substantially Equivalent | 4Web Medical, Inc. | accessdata.fda.gov |
| January 5, 2023 | K221266 | Cervical Spine Truss System (CSTS) Interbody Fusion Device | ODP | Substantially Equivalent | 4Web Medical, Inc. | accessdata.fda.gov |
| September 6, 2022 | K221283 | Hammertoe Truss System (HTS) | HTY | Substantially Equivalent | 4Web Medical, Inc. | accessdata.fda.gov |
| May 18, 2022 | K220463 | Osteotomy Truss System (OTS) | HRS | Substantially Equivalent | 4Web Medical, Inc. | accessdata.fda.gov |
| May 17, 2022 | K212527 | Cervical Spine Truss System Plating Solution (CSTS-PS) | KWQ | Substantially Equivalent | 4Web Medical, Inc. | accessdata.fda.gov |
| August 5, 2021 | K211388 | Lateral Spine Truss System (LSTS) Interbody Fusion Device | MAX | Substantially Equivalent | 4Web Medical, Inc. | accessdata.fda.gov |
| March 10, 2021 | K203065 | Lumbar Spine Truss System Plating Solution (LSTS-PS) | KWQ | Substantially Equivalent | 4Web, Inc. | accessdata.fda.gov |
| May 29, 2020 | K200002 | Anterior Spine Truss System Stand Alone (ASTS-SA) Interbody Fusion Device | OVD | Substantially Equivalent | 4Web, Inc. | accessdata.fda.gov |
| August 12, 2019 | K190870 | Cervical Spinal Truss System-Stand Alone (CSTS-SA) | OVE | Substantially Equivalent | 4Web, Inc. | accessdata.fda.gov |
| July 23, 2019 | K190926 | Hammertoe Truss System (HTS) | HTY | Substantially Equivalent | 4Web, Inc. | accessdata.fda.gov |
| January 8, 2018 | K173159 | Cervical Spinal Truss System (CSTS) Interbody Fusion Device | ODP | Substantially Equivalent | 4Web, Inc. | accessdata.fda.gov |
| November 7, 2017 | K172392 | Lateral Spinal Truss System (LSTS) Interbody Fusion Device | MAX | Substantially Equivalent | 4Web, Inc. | accessdata.fda.gov |
| September 8, 2017 | K171351 | Posterior Spine Truss System (PSTS) Interbody Fusion Device | MAX | Substantially Equivalent | 4Web, Inc. | accessdata.fda.gov |
| August 7, 2017 | K170851 | Anterior Spine Truss System (STS) Interbody Fusion Device | MAX | Substantially Equivalent | 4Web, Inc. | accessdata.fda.gov |
| June 6, 2016 | K153436 | LATERAL Spine Truss System | MAX | Substantially Equivalent | 4Web, Inc. | accessdata.fda.gov |
| April 9, 2015 | K143258 | PLIF STS, TLIF STS, OLIF STS (Spinal Truss System) | MAX | Substantially Equivalent | 4Web, Inc. | accessdata.fda.gov |
| September 23, 2014 | K142112 | 4WEB SPINAL IMPLANT PRODUCTS | MAX | Substantially Equivalent | 4Web, Inc. | accessdata.fda.gov |
| June 7, 2013 | K130185 | 4WEB OSTEOTOMY BONE WEDGE | HRS | Substantially Equivalent | 4-Web, Inc. | accessdata.fda.gov |
| December 14, 2011 | K112316 | 4-WEB ALIF SPINAL TRUSS SYSTEM (STS) | MAX | Substantially Equivalent | 4-Web, Inc. | accessdata.fda.gov |
| January 18, 2011 | K083894 | ALIF SPINAL TRUSS INTERBODY FUSION DEVICE | MAX | Substantially Equivalent | 4-Web Spine, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Intervertebral Fusion Device With Bone Graft, Lumbar
- All makers of Plate, Fixation, Bone
- All makers of Intervertebral Fusion Device With Integrated Fixation, Cervical
- All makers of Intervertebral Fusion Device With Bone Graft, Cervical
- All makers of Intervertebral Fusion Device With Integrated Fixation, Lumbar
- All makers of Appliance, Fixation, Spinal Intervertebral Body
Updated January 28, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.