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FDA 510(k)

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

K-Number: K253201 · 2026-02-12

Applicant4Web, Inc.
Decision Date2026-02-12
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Lumbar Spine Truss System - Plating Solution (LSTS-PS) is a medical device manufactured by 4Web, Inc.. It received FDA 510(k) clearance on 2026-02-12 under approval number K253201. 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 2026-02-12. It is manufactured by 4Web, Inc.. The 510(k) number is K253201.

When was Lumbar Spine Truss System - Plating Solution (LSTS-PS) approved by the FDA?

Lumbar Spine Truss System - Plating Solution (LSTS-PS) received FDA 510(k) clearance on 2026-02-12, under approval number K253201.

What company makes Lumbar Spine Truss System - Plating Solution (LSTS-PS)?

Lumbar Spine Truss System - Plating Solution (LSTS-PS) is manufactured by 4Web, Inc..

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.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT05508360 "Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2) RECRUITING NCT07606729 AI-Driven Programs for Non-specific Chronic Neck Pain ACTIVE_NOT_RECRUITING NCT05438719 MOTUS Total Joint Replacement Investigational Device Exemption Study ACTIVE_NOT_RECRUITING NCT07589023 A Retrospective Review: Outcomes of the REFLECT™ System for Idiopathic Scoliosis NOT_YET_RECRUITING NCT04921488 Interest of Artificial Intelligence in Cancer Screening Colonoscopy COMPLETED

Related PubMed Literature

PMID: 41839575 A Perspective for Integrating Real-World Evidence Into the Investigational Device Exemption Study Design for Lumbar Total Joint Replacement. International journal of spine surgery (2026) PMID: 41160299 Toward safe clinical deployment of remote robotic surgery in Japan: five-year validation of the hinotori™ system using 5G wireless communication. International journal of clinical oncology (2025)

Other Devices by 4Web, Inc.

K153436LATERAL Spine Truss System K172392Lateral Spinal Truss System (LSTS) Interbody Fusion Device K171351Posterior Spine Truss System (PSTS) Interbody Fusion Device K170851Anterior Spine Truss System (STS) Interbody Fusion Device K172294Osteotomy Truss System (OTS) K173159Cervical Spinal Truss System (CSTS) Interbody Fusion Device

View all 11 devices →

Related Devices (Code: KWQ)

K160982Sphynx™Eden Spine, LLC K162638CETRA Anterior Cervical Plate SystemOrthofix, Inc. K162194MEDICREA INTERNATIONAL Anterior Cervical Locking Plate SystemMedicrea International SA K162211AccuFit Lateral Plate SystemPrecision Spine, Inc. K162250FortiBridge Anterior Cervical Plate SystemNanovis Spine, LLC K162664Pyrenees Cervical Plate SystemK2m, Inc.

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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