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510(k) K170611

SETx Pedicle Screw System by Xenco Medical, LLC — Product Code NKB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 25, 2017
Date Received
March 1, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Thoracolumbosacral Pedicle Screw System
Device Class
Class II
Regulation Number
888.3070
Review Panel
OR
Submission Type

Intended to provide immobilization and stabilization of spinal segments in thoracic, lumbar, and sacral spine as an adjunct to fusion.

Other clearances by Xenco Medical, LLC

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  • K223059 — Xenco Medical InterAlign Cervical Interbody System (June 7, 2023)
  • K213456 — Xenco Medical Multilevel CerviKit (December 21, 2021)
  • K191074 — Sorrento Bone Graft Substitute (September 27, 2019)
  • K190364 — CancelleX Porous Titanium Lumbar Interbody Device (April 18, 2019)
  • K173933 — Sorrento Bioglass Bone Graft Substitute (September 13, 2018)
  • K180373 — CancelleX Porous Titanium Lumbar Interbody Device (August 24, 2018)
  • K160313 — Xenco Medical Cervical Interbody System (October 21, 2016)
  • K161478 — Xenco Medical Posterior Cervical System (September 6, 2016)
  • K160986 — Xenco Medical Pedicle Screw System (May 4, 2016)

Other clearances for product code NKB

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  • K253545 — Vulcan Spinal System (February 10, 2026)
  • K252461 — Swedge™ Pedicle Screw Fixation System Bezier Rod (January 13, 2026)
  • K253990 — KHEIRON® Spinal Fixation System, including patient specific K-ROD (January 7, 2026)
  • K253941 — CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly) (January 7, 2026)
  • K253093 — Vital™ Spinal Fixation System (December 17, 2025)
  • K253721 — KHEIRON® Spinal Fixation System, including patient specific K-ROD (December 17, 2025)
  • K252729 — Universal Spinal System (November 18, 2025)
  • K253335 — CD Horizon™ Spinal System (October 24, 2025)