4WEB INC.

FDA Device Registration & Listing · Frisco, TX, US · Registration 3009189869

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
3009189869
FEI Number
3009189869
Entity Name
4WEB INC.
City/State/Country
Frisco, TX, US
Establishment Address
2801 Network Blvd. Suite 620, Frisco, TX 75034, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
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
K221283
PMA Number
N/A

All Registered Proprietary Names

Osteotomy Truss System (OTS) Awl Driver, Screw Bit, Drill Cervical Spine Truss System (CSTS) Interbody Fusion Device 2 PLIF Spine Truss System Posterior Spine Truss System OLIF Spine Truss System TLIF Spine Truss System Hammertoe Truss System (HTS) Cervical Spine Truss System (CSTS) Template Rasp Cervical Spine Truss System - Stand Alone (CSTS-SA) Anterior Spine Truss System - Stand Alone (ASTS-SA) Interbody Fusion Device Inserter Wrench Slap Hammer intervertebral fusion device with bone graft, cervical - Cervical Spine Truss System (CSTS) Intervertebral fusion device with integrated fixation, cervical - Cervical Spine Truss System (CSTS) Anterior Spine Truss System (ASTS) Interbody Fusion Device Anterior Spine Truss System (ASTS) Anterior Spine Truss System (STS) Interbody Fusion Device Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device Instrument Kit Sterile Packaged Osteotomy Truss System Sterile Packaged Posterior Spine Truss System Sterile Packaged Cervical Spine Truss System Sterile Packaged ALIF Spine Truss System Lateral STS Lateral Spine Truss System Retractor Cervical Spine Truss System (CSTS) Interbody Fusion Device Cervical Spine Truss System (CSTS) Mallet Lumbar Spine Truss System Plating Solution (LSTS-PS) Sacroiliac Joint Truss System (SJTS) Osteotome Lateral Cobb Intervertebral fusion device with bone graft, lumbar Intervertebral fusion device with integrated fixation, lumbar Lateral Spine Truss System (LSTS) Tray, Instrument Lateral Spine Truss System (LSTS) Lateral Spine Truss System (LSTS) Interbody Fusion Device Cervical Spine Truss System Plating Solution (CSTS-PS) Ankle Truss System (ATS) Inserter Sleeve Box Cutter Distractor Caddy Lid Suction Tube Slider Targeting Tool Handle Shaver Posterior Spine Truss System (PSTS) Posterior Spine Truss System (PSTS) Interbody Fusion Device Curette Annulotomy Knife Osteotomy Truss System (OTS) 4WEB Osteotomy Wedge Osteotomy Truss System Cervical Spine Truss System Cervical STS Hammertoe Truss System (HTS)

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2022-12-16
HWJ Awl Orthopedic Class 1 888.4540 2020-10-27
HXX Screwdriver Orthopedic Class 1 888.4540 2020-10-27
HTW Bit, Drill Orthopedic Class 1 888.4540 2020-10-27
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2023-01-26
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2015-10-16
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2020-04-23
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2023-11-10
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2023-11-10
HWT Template Orthopedic Class 1 888.4800 2020-10-27
HTR Rasp General, Plastic Surgery Class 1 878.4800 2020-10-27
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2026-02-09
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2020-09-16
HXC Wrench Orthopedic Class 1 888.4540 2023-02-24
HWA Impactor Orthopedic Class 1 888.4540 2020-10-27
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
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2018-08-29
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2019-10-03
KDD Kit, Surgical Instrument, Disposable General, Plastic Surgery Class 1 878.4800 2020-11-18
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2015-10-16
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 2016-11-05
GAD Retractor General, Plastic Surgery Class 1 878.4800 2020-10-27
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2018-08-29
GFJ Mallet, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2023-07-18
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2021-03-10
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2021-03-10
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2026-02-09
OUR Sacroiliac Joint Fixation Orthopedic Class 2 888.3040 2026-02-09
HWM Osteotome General, Plastic Surgery Class 1 878.4800 2020-10-27
HTE Elevator General, Plastic Surgery Class 1 878.4800 2020-11-18
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2021-08-23
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2021-08-23
FSM Tray, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2020-11-11
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2018-08-29
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2022-12-16
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
MDM Instrument, Manual, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2013-09-20
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2018-08-29
HTF Curette General, Plastic Surgery Class 1 878.4800 2020-10-27
HTS Knife, Orthopedic Orthopedic Class 1 888.4540 2020-11-18
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2018-08-29
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2014-12-15
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2012-11-13
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2022-12-16

Official Correspondent

Upasana Veturi

US Agent Details

No US Agent registered (Local establishment).

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
3011127597 4WEB EU B.V. Assendelft Noord-Holland, NL

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K042598 Zimmer, Inc. PERIARTICULAR LOCKING PLATES AND SCREWS, 2357 AND 2359 SERIES 2004-10-29
K190842 Jiangsu Trauhui Medical Instrument Co., Ltd. Comus Locking Plate systems 2020-02-03
K130510 Arthrex, Inc. ARTHREX COMPRESSION PLATES 2013-09-25
K202803 Newclip Technics Activmotion S DTO 2021-12-16
K142269 Reliance Medical Systems, LLC Reliance Cervical IBF System 2015-06-09

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0034-2022 Flower Orthopedics Corporation 2
Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201
Z-0013-05 Biomet, Inc. 2
Lactosorb pin, 2.0 x 20 mm, sterile; ref. 948205.
Z-0010-2008 N/A 1
EPIK KNEE SYSTEM Angled Insert Impactor RM/LL; Part #801-03-052 Rev. A; non-sterile; knee prosthesis instrument. Distributed by Encore Medical, L.P., Austin, TX 78758.
Z-0031-2014 Aesculap, Inc. 1
UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during surgical procedures.
Z-0036-2013 Medtronic Sofamor Danek USA Inc 2
ATLANTIS(R) Anterior Cervical Plate System VARIABLE ANGLE SCREW MODULE, REF 176-503, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009189869. Last updated year: 2026. Please use registration number 3009189869 when referencing this establishment in official correspondence.
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