Home / 510(k) Clearances / K173198

510(k) K173198

Facet Screw Fixation System by U&I Corporation — Product Code MRW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 3, 2018
Date Received
October 2, 2017
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 U&I Corporation

  • K220147 — Aspiron S ACP System (February 16, 2022)
  • K210573 — Velofix SA Cervical Cage (November 19, 2021)
  • K183243 — Velofix TLIF Cage (July 10, 2019)
  • K190067 — Velofix Interbody Fusion System (February 4, 2019)
  • K190053 — SECULOK™ ACP System (February 1, 2019)
  • K181824 — CBT Screw Fixation System (December 13, 2018)
  • K183383 — ANAX™ OCT Spinal System (December 12, 2018)
  • K181829 — Velofix TLIF Cage (November 14, 2018)
  • K182055 — SECULOK™ ACP System (September 10, 2018)
  • K180759 — SECULOK™ Suture Anchor (August 9, 2018)

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)