4WEB INC.
Registration 3009189869FEI 3009189869Frisco, TX
Owner/operator: 4WEB, INC
- Develop Specifications But Do Not Manufacture At This Facility
Renewal due by December 31, 2026
Registered through 2026. Renew between October 1 and December 31, 2026, to stay registered for 2027.
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The 2026 window
- Oct 1Window opens91 days left
- Nov 3Where you stand58 days left
- Dec 1Our pay-by date30 days left
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- FDA fee, FY2027
- $13,785
- Our pay-by suggestion
- Dec 1
- Listed devices
- 57
- Added, last 12 months
- 3
FDA sets who pays the fee and who may qualify for a waiver; its fee page says so. The fee is paid only on FDA’s own fee site. Never through us. FDA’s fee page
The steps, in order
Pay FDA's annual feeYou
Order and pay the FY2027 establishment fee on FDA's Device Facility User Fee site. FDA emails you a PIN when you order.
FDA: registration and listing payment processWait for the payment confirmation numberYou
FDA emails a Payment Confirmation Number (PCN) once the payment processes, which FDA says typically takes several days. That is why we suggest paying by December 1.
FDA: registration and listing payment processRenew the registration in FDA's systemYou
Sign in to FDA's Unified Registration and Listing System (FURLS), complete the annual registration and apply your PIN and PCN. FDA does not count the registration as complete until both are applied.
FDA: device registration and listingReview every listingYou
In the same window, review each listing on file and report any changes, deletions and new listings. Your Listing Review Sheet puts every listing on one page.
FDA: device registration and listing
Every listed device 57
| Code | Device | Class | Regulation | Premarket |
|---|---|---|---|---|
| SAI | Ankle Truss System (ATS)Ankle Fusion Cage | Class 2 | 21 CFR 888.3020 | K230088 |
| KWQ | Lumbar Spine Truss System Plating Solution (LSTS-PS)Appliance, Fixation, Spinal Intervertebral Body | Class 2 | 21 CFR 888.3060 | K203065 |
| KWQ | Cervical Spine Truss System Plating Solution (CSTS-PS)Appliance, Fixation, Spinal Intervertebral Body | Class 2 | 21 CFR 888.3060 | K212527 |
| ODP | Cervical STSIntervertebral Fusion Device With Bone Graft, Cervical | Class 2 | 21 CFR 888.3080 | K121741 |
| ODP | Cervical Spine Truss System (CSTS)Intervertebral Fusion Device With Bone Graft, Cervical | Class 2 | 21 CFR 888.3080 | K173159 |
| ODP | Cervical Spine Truss System (CSTS) Interbody Fusion Device 2Intervertebral Fusion Device With Bone Graft, Cervical | Class 2 | 21 CFR 888.3080 | K221266 |
| ODP | Cervical Spine Truss System (CSTS)Intervertebral Fusion Device With Bone Graft, Cervical | Class 2 | 21 CFR 888.3080 | K231739 |
| ODP | Intervertebral fusion device with integrated fixation, cervical - Cervical Spine Truss System (CSTS)Intervertebral Fusion Device With Bone Graft, Cervical | Class 2 | 21 CFR 888.3080 | K251117 |
| ODP | Sterile Packaged ALIF Spine Truss SystemIntervertebral Fusion Device With Bone Graft, Cervical | Class 2 | 21 CFR 888.3080 | K142112 |
| MAX | Lateral STSIntervertebral Fusion Device With Bone Graft, Lumbar | Class 2 | 21 CFR 888.3080 | K153436 |
| MAX | Intervertebral fusion device with bone graft, lumbarIntervertebral Fusion Device With Bone Graft, Lumbar | Class 2 | 21 CFR 888.3080 | K211388 |
| MAX | ALIF Spine Truss SystemIntervertebral Fusion Device With Bone Graft, Lumbar | Class 2 | 21 CFR 888.3080 | K112316 |
and 45 more on your full dossier
What changed
- Feb 9, 2026Listing added: OVE — Cervical Spine Truss System - Stand Alone (CSTS-SA) (K253200)
- Feb 9, 2026Listing added: OUR — Sacroiliac Joint Truss System (SJTS) (K252834)
- Feb 9, 2026Listing added: HWC — Sacroiliac Joint Truss System (SJTS) (K252834)