4WEB Inc.
Frisco, TX, US
4WEB INC. appears in FDA device records in Frisco, TX. FDA records list 12 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to 4WEB Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- 4-Web Inc.recall
510(k) clearance history
FDA records hold 12 510(k) clearances for 4WEB Inc. between 2015 and 2026. The busiest year on record is 2017, with 3. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2015 | 1 |
| 2016 | 1 |
| 2017 | 3 |
| 2018 | 2 |
| 2019 | 2 |
| 2020 | 1 |
| 2021 | 1 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K253201 | Lumbar Spine Truss System - Plating Solution (LSTS-PS) | KWQ | Substantially Equivalent | |
| K203065 | Lumbar Spine Truss System Plating Solution (LSTS-PS) | KWQ | Substantially Equivalent | |
| K200002 | Anterior Spine Truss System – Stand Alone (ASTS-SA) Interbody Fusion Device | OVD | Substantially Equivalent | |
| K190870 | Cervical Spinal Truss System-Stand Alone (CSTS-SA) | OVE | Substantially Equivalent | |
| K190926 | Hammertoe Truss System (HTS) | HTY | Substantially Equivalent | |
| K172294 | Osteotomy Truss System (OTS) | HRS | Substantially Equivalent | |
| K173159 | Cervical Spinal Truss System (CSTS) Interbody Fusion Device | ODP | Substantially Equivalent | |
| K172392 | Lateral Spinal Truss System (LSTS) Interbody Fusion Device | MAX | Substantially Equivalent | |
| K171351 | Posterior Spine Truss System (PSTS) Interbody Fusion Device | MAX | Substantially Equivalent | |
| K170851 | Anterior Spine Truss System (STS) Interbody Fusion Device | MAX | Substantially Equivalent | |
| K153436 | LATERAL Spine Truss System | MAX | Substantially Equivalent | |
| K143258 | PLIF STS, TLIF STS, OLIF STS (Spinal Truss System) | MAX | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3009189869 | 3009189869 | 4WEB INC. | 2801 Network Blvd. Suite 620, Frisco, TX 75034 US | 2026 | and 23 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- SAIAnkle Fusion Cage
- KWQAppliance, Fixation, Spinal Intervertebral Body
- HWJAwl
- HXWBender
- HTWBit, Drill
- HTFCurette
- HTEElevator
- FZXGuide, Surgical, Instrument
- HWAImpactor
- MDMInstrument, Manual, Surgical, General Use
- ODPIntervertebral Fusion Device With Bone Graft, Cervical
- MAXIntervertebral Fusion Device With Bone Graft, Lumbar
- OVEIntervertebral Fusion Device With Integrated Fixation, Cervical
- OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar
- KDDKit, Surgical Instrument, Disposable
- HTSKnife, Orthopedic
- HXLMallet
- GFJMallet, Surgical, General & Plastic Surgery
- LXHOrthopedic Manual Surgical Instrument
- HWMOsteotome
- HTYPin, Fixation, Smooth
- HRSPlate, Fixation, Bone
- HTRRasp
- GADRetractor
- HSBRod, Fixation, Intramedullary And Accessories
- HTXRongeur
- OURSacroiliac Joint Fixation
- HWCScrew, Fixation, Bone
- HXXScrewdriver
- HXGTamp
- HWTTemplate
- FSMTray, Surgical, Instrument
- HXCWrench
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0812-2015 | ASTS-LG1212: Anterior Lumbar Interbody Fusion Spine Truss System (orthopedic implant) Large, 12 degrees lordosis, 12 mm height and ASTS-LG0612: Anterior Lumbar Interbody Fusion Spine Truss System (orthopedic implant) Large, 6 degrees lordosis, 12 mm height | Product is mislabeled. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain