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510(k) K243865

AERO MIS Facet Fusion System by Aurora Spine — Product Code MRW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 24, 2025
Date Received
December 17, 2024
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 Aurora Spine

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  • K221399 — ZIP™ MIS Interspinous Fusion System (July 8, 2022)
  • K220610 — SOLO-L (May 27, 2022)
  • K210521 — DEXA-C Cervical Interbody System (August 2, 2021)
  • K210325 — APOLLO Anterior Cervical Plate (ACP) System (March 23, 2021)
  • K141317 — ZIP MIS INTERSPINOUS FUSION SYSTEM (November 17, 2014)
  • K140715 — ZIP MIS INTERSPINOUS FUSION SYSTEM (April 17, 2014)
  • K133967 — INTERBODY CAGE SYSTEM (January 31, 2014)
  • K133091 — ZIP MIS INTERSPINOUS FUSION SYSTEM (November 27, 2013)

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)
  • 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)