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FDA 510(k)

Lumbar Spine Truss System Plating Solution (LSTS-PS)

K-Number: K203065 · 2021-03-10

Applicant4Web, Inc.
Decision Date2021-03-10
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Lumbar Spine Truss System Plating Solution (LSTS-PS) is the device name listed in this FDA 510(k) record. The listed applicant is 4Web, Inc.. It received FDA 510(k) clearance on 2021-03-10 under 510(k) number K203065. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Lumbar Spine Truss System Plating Solution (LSTS-PS)?

Lumbar Spine Truss System Plating Solution (LSTS-PS) is a medical device that received FDA 510(k) clearance on 2021-03-10. The listed applicant is 4Web, Inc.. The 510(k) number is K203065.

When did Lumbar Spine Truss System Plating Solution (LSTS-PS) receive FDA 510(k) clearance?

Lumbar Spine Truss System Plating Solution (LSTS-PS) received FDA 510(k) clearance on 2021-03-10, under 510(k) number K203065.

Who is the listed applicant for Lumbar Spine Truss System Plating Solution (LSTS-PS)?

The FDA 510(k) record lists 4Web, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Lumbar Spine Truss System Plating Solution (LSTS-PS)?

The FDA product code for Lumbar Spine Truss System Plating Solution (LSTS-PS) is KWQ.

Other records listing 4Web, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253201Lumbar Spine Truss System - Plating Solution (LSTS-PS)K200002Anterior Spine Truss System – Stand Alone (ASTS-SA) Interbody Fusion DeviceK190870Cervical Spinal Truss System-Stand Alone (CSTS-SA)K190926Hammertoe Truss System (HTS)K172294Osteotomy Truss System (OTS)K173159Cervical Spinal Truss System (CSTS) Interbody Fusion Device

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Related Devices (Code: KWQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261309Palisades™ Buttress Plate SystemBethesda Medical Devices, LLCK252776ARIES Anterior Cervical Plate SystemsZheJiang Decans Medical Devices Co., Ltd.K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.K260570corra™ cervical plating systemCarlsmed, Inc.K260697VyPlate™ Anterior Cervical Plate SystemVy Spine, LLCK260015ANTERIS Thoracolumbar Plate SystemSpineCraft

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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