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510(k) K252153

FFX Facet Fixation System by Sc Medica — Product Code MRW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 16, 2025
Date Received
July 9, 2025
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 Sc Medica

  • K250679 — FFX Facet Fixation System (December 4, 2025)
  • K232468 — SC Medica FFX (May 9, 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)
  • 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)
  • K241035 — PMT Posterior Cervical Stabilization System (PCSS) (June 25, 2024)