Data / Medical devices / United States / 4web Inc.

4web Inc.: FDA-registered device maker in Frisco, TX, United States, 28 510(k) clearances

Name: 4web Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

4web Inc. is registered with the FDA (registration 3009189869) in Frisco, TX, United States. It lists 33 device types. The FDA files 28 510(k) clearances under its listings, the newest dated January 28, 2026. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3009189869
Address: 2801 Network Blvd. Suite 620, Frisco, TX, United States, 75034
Owner or operator: 4WEB, INC (10037722)
Roles: Specification developer
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	Specification developer	accessdata.fda.gov
Appliance, Fixation, Spinal Intervertebral Body	KWQ	2	Specification developer	accessdata.fda.gov
Awl	HWJ	1	Specification developer	accessdata.fda.gov
Bender	HXW	1	Specification developer	accessdata.fda.gov
Bit, Drill	HTW	1	Specification developer	accessdata.fda.gov
Curette	HTF	1	Specification developer	accessdata.fda.gov
Elevator	HTE	1	Specification developer	accessdata.fda.gov
Guide, Surgical, Instrument	FZX	1	Specification developer	accessdata.fda.gov
Impactor	HWA	1	Specification developer	accessdata.fda.gov
Instrument, Manual, Surgical, General Use	MDM	1	Specification developer	accessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, Cervical	ODP	2	Specification developer	accessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, Lumbar	MAX	2	Specification developer	accessdata.fda.gov
Intervertebral Fusion Device With Integrated Fixation, Cervical	OVE	2	Specification developer	accessdata.fda.gov
Intervertebral Fusion Device With Integrated Fixation, Lumbar	OVD	2	Specification developer	accessdata.fda.gov
Kit, Surgical Instrument, Disposable	KDD	1	Specification developer	accessdata.fda.gov
Knife, Orthopedic	HTS	1	Specification developer	accessdata.fda.gov
Mallet	HXL	1	Specification developer	accessdata.fda.gov
Mallet, Surgical, General & Plastic Surgery	GFJ	1	Specification developer	accessdata.fda.gov
Orthopedic Manual Surgical Instrument	LXH	1	Specification developer	accessdata.fda.gov
Osteotome	HWM	1	Specification developer	accessdata.fda.gov
Pin, Fixation, Smooth	HTY	2	Specification developer	accessdata.fda.gov
Plate, Fixation, Bone	HRS	2	Specification developer	accessdata.fda.gov
Rasp	HTR	1	Specification developer	accessdata.fda.gov
Retractor	GAD	1	Specification developer	accessdata.fda.gov
Rod, Fixation, Intramedullary And Accessories	HSB	2	Specification developer	accessdata.fda.gov
Rongeur	HTX	1	Specification developer	accessdata.fda.gov
Sacroiliac Joint Fixation	OUR	2	Specification developer	accessdata.fda.gov
Screw, Fixation, Bone	HWC	2	Specification developer	accessdata.fda.gov
Screwdriver	HXX	1	Specification developer	accessdata.fda.gov
Tamp	HXG	1	Specification developer	accessdata.fda.gov
Template	HWT	1	Specification developer	accessdata.fda.gov
Tray, Surgical, Instrument	FSM	1	Specification developer	accessdata.fda.gov
Wrench	HXC	1	Specification developer	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
February 22, 2018	K172294	Osteotomy Truss System (OTS)	HRS	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
October 18, 2012	K121741	4-WEB CERVICAL STS (SPINAL TRUSS SYSTEM)	ODP	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

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
September 29, 2014	69662	Class II	Terminated	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) Lar	Product is mislabeled.	accessdata.fda.gov

Compare with other makers

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.