4WEB Inc.
United Statesfrom the FDA registration address FDA establishment FEI 3009189869
- Devices
- 16
- Registrations
- FDA
- FDA recalls
- 1
What 4WEB Inc. makes
4WEB Inc. manufactures spinal fusion and osteotomy systems, including interbody fusion devices for cervical, lumbar, and lateral spine applications. Their portfolio includes truss-based solutions for posterior, anterior, and stand-alone spinal stabilization, as well as a dedicated hammertoe correction system. These devices are designed for use in spinal surgeries requiring structural support or bone alignment adjustments.
The company’s products are classified as Class II medical devices under FDA regulations and are authorised via the 510(k) clearance pathway. The portfolio is listed in the FDA’s 510(k) database, reflecting compliance with U.S. regulatory requirements. The manufacturer is based in the United States.
Catalogue
Search and filter all 16 devicesCompany details
- FDA FEI number
- 3009189869
- Address
- 2801 Network Blvd. Suite 620, Frisco, TX, 75034
FDA recalls
FDA recall records list 1 recall initiated by 4WEB INC., initiated on 2014-09-29. By recorded status: 1 terminated. The reasons filed fall into these groups: labeling or instructions for use. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2014
- 29 Sep 2014 Z-0812-2015 Class II Terminated Product is mislabeled.
Frequently asked questions
How many devices does 4WEB INC. have in the registry?
The registry currently lists 16 devices for 4WEB INC.. Devices recorded under merged duplicate company entries are counted once.
Which registries list 4WEB INC.'s devices?
Among its 16 most recently registered devices, 4WEB INC. has devices listed in FDA 510(k) (16 devices).
What risk classes do 4WEB INC.'s devices fall under?
Among its 16 most recently registered devices, the classes recorded for 4WEB INC.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for 4WEB INC.?
FDA recall records list 1 recall initiated by 4WEB INC., the most recent initiated on 29 Sep 2014. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from 4WEB INC. in the registry?
The most recently registered devices listed for 4WEB INC. include PLIF STS, TLIF STS, OLIF STS (Spinal Truss System), Posterior Spine Truss System (PSTS) Interbody Fusion Device, Anterior Spine Truss System – Stand Alone (ASTS-SA) Interbody Fusion Device and Cervical Spinal Truss System (CSTS) Interbody Fusion Device.