Home / 510(k) Clearances / K220441

510(k) K220441

CYGNUS™ MoRe Anterior Cervical Plate System by MiRus, LLC — Product Code KWQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 16, 2022
Date Received
February 16, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Appliance, Fixation, Spinal Intervertebral Body
Device Class
Class II
Regulation Number
888.3060
Review Panel
OR
Submission Type

Other clearances by MiRus, LLC

  • K252733 — ATLAS™ Expandable Osteotomy Wedge System (February 19, 2026)
  • K242516 — EUROPA™ Posterior Cervical Fusion System (November 19, 2024)
  • K241175 — MiRus MoRe Lumbar Plating System (May 17, 2024)
  • K232348 — RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion System (October 27, 2023)
  • K232481 — RIGEL™ 3DR Anterior Cervical Corpectomy System (October 13, 2023)
  • K232154 — MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate Fixation (September 11, 2023)
  • K230369 — EUROPA™ Navigated Instruments (June 23, 2023)
  • K220115 — ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion System (May 13, 2022)
  • K210800 — IO Expandable Lumbar Interbody Fusion System (August 20, 2021)
  • K200685 — RIGEL 3DR Anterior Cervical Interbody Fusion System (June 11, 2020)

Other clearances for product code KWQ

  • K260015 — ANTERIS Thoracolumbar Plate System (March 4, 2026)
  • K251940 — PathLoc Lumbar Plate System (March 3, 2026)
  • K254182 — Aster (February 26, 2026)
  • K253201 — Lumbar Spine Truss System - Plating Solution (LSTS-PS) (February 12, 2026)
  • K252611 — aprevo® cervical plating system (December 22, 2025)
  • K251965 — Proximity Anterior Cervical Plate System; Segmental Plating System (SPS) (August 28, 2025)
  • K251436 — Resolve Anterior Cervical Plate System (July 11, 2025)
  • K250446 — Frida™ Anterior Cervical Plate System (May 23, 2025)
  • K250602 — X-PAC® N-GAGE™ Lumbar Plate System (May 20, 2025)
  • K250486 — Skyway Anterior Cervical Plate System (April 10, 2025)