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510(k) K233951

CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw) by Medtronic Sofamor Danek USA, Inc. — Product Code NKB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 27, 2024
Date Received
December 15, 2023
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 Medtronic Sofamor Danek USA, Inc.

  • K254165 — Infinity™ OCT System (January 21, 2026)
  • K253941 — CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly) (January 7, 2026)
  • K253129 — Infinity™ OCT System (October 24, 2025)
  • K253335 — CD Horizon™ Spinal System (October 24, 2025)
  • K251444 — Endoskeleton™ Interbody Systems (September 4, 2025)
  • K251395 — The Rialto™ SI Fusion System (June 26, 2025)
  • K250669 — Adaptix™ Interbody System with Titan nanoLOCK™ Surface Technology (April 22, 2025)
  • K241992 — Catalyft™ LS Expandable Interbody System (October 28, 2024)
  • K243007 — CD Horizon™ Spinal System (October 23, 2024)
  • K233830 — OsteoCool™ 2.0 RF Ablation System (February 28, 2024)

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)