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510(k) K203065

Lumbar Spine Truss System Plating Solution (LSTS-PS) by 4Web, Inc. — Product Code KWQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 10, 2021
Date Received
October 9, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Appliance, Fixation, Spinal Intervertebral Body
Device Class
Class II
Regulation Number
888.3060
Review Panel
OR
Submission Type

Other clearances by 4Web, Inc.

  • K253201 — Lumbar Spine Truss System - Plating Solution (LSTS-PS) (February 12, 2026)
  • K200002 — Anterior Spine Truss System – Stand Alone (ASTS-SA) Interbody Fusion Device (May 29, 2020)
  • K190870 — Cervical Spinal Truss System-Stand Alone (CSTS-SA) (August 12, 2019)
  • K190926 — Hammertoe Truss System (HTS) (July 23, 2019)
  • K172294 — Osteotomy Truss System (OTS) (February 22, 2018)
  • K173159 — Cervical Spinal Truss System (CSTS) Interbody Fusion Device (January 8, 2018)
  • K172392 — Lateral Spinal Truss System (LSTS) Interbody Fusion Device (November 7, 2017)
  • K171351 — Posterior Spine Truss System (PSTS) Interbody Fusion Device (September 8, 2017)
  • K170851 — Anterior Spine Truss System (STS) Interbody Fusion Device (August 7, 2017)
  • K153436 — LATERAL Spine Truss System (June 6, 2016)

Other clearances for product code KWQ

  • K260015 — ANTERIS Thoracolumbar Plate System (March 4, 2026)
  • K251940 — PathLoc Lumbar Plate System (March 3, 2026)
  • K254182 — Aster (February 26, 2026)
  • K253201 — Lumbar Spine Truss System - Plating Solution (LSTS-PS) (February 12, 2026)
  • K252611 — aprevo® cervical plating system (December 22, 2025)
  • K251965 — Proximity Anterior Cervical Plate System; Segmental Plating System (SPS) (August 28, 2025)
  • K251436 — Resolve Anterior Cervical Plate System (July 11, 2025)
  • K250446 — Frida™ Anterior Cervical Plate System (May 23, 2025)
  • K250602 — X-PAC® N-GAGE™ Lumbar Plate System (May 20, 2025)
  • K250486 — Skyway Anterior Cervical Plate System (April 10, 2025)