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510(k) K222515

FaSet Fixation System by Dio Medical Corporation — Product Code MRW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 5, 2022
Date Received
August 19, 2022
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 Dio Medical Corporation

  • K222415 — Rexious Spinal Fixation System (October 25, 2022)
  • K222572 — FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate Syst (October 18, 2022)
  • K222448 — UNITY Sacroiliac Joint Fixation System (October 13, 2022)

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)