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4-WEB Cervical Sts (Spinal Truss System)

by 4WEB Inc.

510(k) K121741

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK121741 Date18 Oct 2012ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
ODP
FDA applicant
4-Web, Inc.
Device Class
Class II
Regulation
21 CFR Part 888.3080
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The 4-Web Cervical Sts (Spinal Truss System) is a spinal truss system designed for cervical spine applications. It incorporates a proprietary truss implant technology, which transfers strain to adjacent cellular material under normal loading conditions, stimulating a mechanobiologic response.

The device is supplied as a stand-alone system and is designed to provide high strength structures with hierarchical surface roughness, allowing for cell adhesion and osteogenesis throughout the entire fusion column. It is authorized under FDA 510K clearance and has been found to be substantially equivalent. The device is available in a specific configuration, as indicated by its product code ODP.

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Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the 4-Web Cervical STS used for?

    The 4-Web Cervical STS is used for cervical spine applications, providing high strength structures for cell adhesion and osteogenesis throughout the entire fusion column.

  • How is the 4-Web Cervical STS supplied?

    The 4-Web Cervical STS is supplied as a stand-alone system, available in a specific configuration as indicated by its product code ODP.

  • Is the 4-Web Cervical STS authorized by the FDA?

    Yes, the 4-Web Cervical STS is authorized under FDA 510K clearance and has been found to be substantially equivalent.