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510(k) K230840

PMT Facet Fixation System, Lumbar (PMT FFS-LX) by Providence Medical Technology, Inc. — Product Code MRW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 19, 2023
Date Received
March 27, 2023
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.

  • 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)
  • 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)
  • K183589 — PMT Facet Screw (October 11, 2019)
  • K190201 — CORUS Spinal System (March 8, 2019)

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)