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510(k) K241416

Ion 3D by SurGenTec, LLC — Product Code MRW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 17, 2024
Date Received
May 17, 2024
Clearance Type
Special
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 SurGenTec, LLC

  • K251714 — Ion-C (January 16, 2026)
  • K251720 — OsteoFlo HydroFiber (July 2, 2025)
  • K243949 — OsteoFlo HydroFiber (May 28, 2025)
  • K243945 — ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit) (April 24, 2025)
  • K243580 — GraftGun Universal Graft Delivery System (GDS) (February 5, 2025)
  • K243835 — TiLink-P SI Joint Fusion System (December 27, 2024)
  • K242797 — OsteoFlo HydroFiber (December 23, 2024)
  • K243265 — Ion 3D (December 4, 2024)
  • K242414 — TiLink-P Joint Fusion System (November 21, 2024)
  • K242141 — TiLink-P SI Joint Fusion System (August 21, 2024)

Other clearances for product code MRW

  • K251714 — Ion-C (January 16, 2026)
  • K250679 — FFX Facet Fixation System (December 4, 2025)
  • 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)