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510(k) K253676

CORUS™ Posterior Cervical Stabilization System 3D (CORUS™ PCSS 3D) by Providence Medical Technology, Inc. — Product Code MRW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 14, 2026
Date Received
November 21, 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 Providence Medical Technology, Inc.

  • K261665 — CORUS™ Navigation System-GN (June 18, 2026)
  • K253190 — CORUS-LX Implant (November 20, 2025)
  • K251060 — CORUS™ Navigation System-GX (July 30, 2025)
  • K251885 — CAVUX Facet Fixation System (CAVUX FFS) and CORUS-LX Implant (July 10, 2025)
  • K241035 — PMT Posterior Cervical Stabilization System (PCSS) (June 25, 2024)
  • K240625 — CORUS Navigation Access System (May 3, 2024)
  • K230840 — PMT Facet Fixation System, Lumbar (PMT FFS-LX) (December 19, 2023)
  • K230297 — PMT Expandable Cage (PMT EXP) (August 11, 2023)
  • K220951 — PMT Facet Fixation System (PMT FFS) (December 9, 2022)
  • K212636 — CORUS Spinal System-X (October 15, 2021)

Other clearances for product code MRW

  • K261209 — Ion-L (June 11, 2026)
  • K253432 — DiversiVy™ Facet Screw System (March 19, 2026)
  • 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)