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510(k) K180153

X-spine Cortical Bone Screw System by X-Spine Systems, Inc. — Product Code NKB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 15, 2018
Date Received
January 19, 2018
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 X-Spine Systems, Inc.

  • K173832 — InTice™-C Porous Ti Cervical Interbody System (May 17, 2018)
  • K170119 — Calix Lumbar Spinal Implant System (September 29, 2017)
  • K171567 — IRIX-A Lumbar Integrated Fusion System (August 28, 2017)
  • K171075 — Calix-C Cervical Interbody Spacer (August 1, 2017)
  • K170224 — Spider Cervical Plating System (July 6, 2017)
  • K170530 — Butrex Lumbar Buttress Plating System (March 22, 2017)
  • K160959 — Xsert Lumbar Expandable Interbody System (November 17, 2016)
  • K162944 — Irix-C Cervical Integrated Fusion System (November 7, 2016)
  • K160428 — Certex Spinal Fixation System (May 5, 2016)
  • K160114 — Xspan Laminoplasty Fixation System (March 15, 2016)

Other clearances for product code NKB

  • K254247 — OSTEOMNI SPINAL FIXATION SYSTEM (February 24, 2026)
  • K253169 — Duet™ Spinal Fixation System (February 23, 2026)
  • 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)