510(k) K232348

RIGEL 3DR Standalone Anterior Cervical Interbody Fusion System by MiRus, LLC — Product Code OVE

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: October 27, 2023
Date Received: August 7, 2023
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Intervertebral Fusion Device With Integrated Fixation, Cervical
Device Class: Class II
Regulation Number: 888.3080
Review Panel: OR
Submission Type

Intended to stabilize cervical spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft with or without supplemental fixation.

Other clearances by MiRus, LLC

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K242516 — EUROPA Posterior Cervical Fusion System (November 19, 2024)
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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)
K220441 — CYGNUS MoRe Anterior Cervical Plate System (September 16, 2022)
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 OVE

K260038 — E3D-C Interbody System (February 4, 2026)
K253876 — HEDRON Cervical Spacers (HEDRON C-MIS Spacer) (December 22, 2025)
K253200 — Cervical Spine Truss System - Stand Alone (CSTS-SA) (December 11, 2025)
K250076 — Endeavor Stand-Alone Cervical IBF System (September 25, 2025)
K250540 — SABER-C System (August 8, 2025)
K251735 — Stabilis SA Cervical Stand-Alone System (Various PNs) (July 30, 2025)
K251431 — FIX-C PEEK ACIF SA System (June 27, 2025)
K251117 — Cervical Spine Truss System (CSTS) (April 25, 2025)
K242928 — Tesera-k SC System (April 10, 2025)
K243188 — CYLOX® ST (February 11, 2025)