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510(k) K240085

zLOCK Lumbar Facet Fixation System by Zygofix , Ltd. — Product Code MRW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 18, 2024
Date Received
January 11, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Facet Screw Spinal Device
Device Class
Class U
Regulation Number
Review Panel
OR
Submission Type

Other clearances by Zygofix , Ltd.

  • K242650 — zLOCK Lumbar Facet Fixation System (September 20, 2024)

Other clearances for product code MRW

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  • K253190 — CORUS-LX Implant (November 20, 2025)
  • K252153 — FFX Facet Fixation System (October 16, 2025)
  • K251885 — CAVUX Facet Fixation System (CAVUX FFS) and CORUS-LX Implant (July 10, 2025)
  • K250920 — Arthrex Spine Compression FT Screw (May 22, 2025)
  • K242527 — The Karma® Fixation System (May 21, 2025)
  • K243865 — AERO MIS Facet Fusion System (March 24, 2025)
  • K243265 — Ion 3D (December 4, 2024)
  • K242650 — zLOCK Lumbar Facet Fixation System (September 20, 2024)