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Lumbar Spine Truss System - Plating Solution (LSTS-PS)

by 4WEB Inc.

510(k) K253201

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 · Special NumberK253201 Date12 Feb 2026ClearedStatusActive

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  • Withdrawn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
KWQ
FDA applicant
4Web, Inc.
Device Class
Class II
Regulation
21 CFR Part 888.3060
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 Sep 2026

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

The Lumbar Spine Truss System - Plating Solution (LSTS-PS) is a laterally placed supplemental fixation device intended for use in the lumbar spine. It is designed to be used via lateral, anterolateral, or anterior surgical approaches relative to the great vessels.

The device is supplied non-sterile and is intended for single-use. It is authorized under FDA 510(k) clearance (K253201) and is classified under product code KWQ with orthopedic advisory committee review. No MRI safety information, sizes, or storage conditions are provided in the data.

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Questions

AI-generated answers, 24 Sep 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 Lumbar Spine Truss System - Plating Solution (LSTS-PS) used for?

    The Lumbar Spine Truss System - Plating Solution (LSTS-PS) is a laterally placed supplemental fixation device intended for use in the lumbar spine, designed to be used via lateral, anterolateral, or anterior surgical approaches relative to the great vessels.

  • How is the Lumbar Spine Truss System - Plating Solution (LSTS-PS) supplied and is it reusable?

    The device is supplied non-sterile and is intended for single-use only, meaning it should not be reprocessed or reused after initial implantation to maintain safety and performance.

  • What regulatory pathway was used for the Lumbar Spine Truss System - Plating Solution (LSTS-PS)?

    The Lumbar Spine Truss System - Plating Solution (LSTS-PS) received FDA 510(k) clearance under K253201 and was found substantially equivalent to a predicate device, with review by the Orthopedic Advisory Committee under product code KWQ.