Cleared Traditional

RIGEL? 3DR Standalone Anterior Cervical Interbody Fusion System

K232348 · MiRus, LLC · Orthopedic

Oct 2023

Decision

81d

Days

Class 2

Risk

About This 510(k) Submission

K232348 is an FDA 510(k) clearance for the RIGEL? 3DR Standalone Anterior Cervical Interbody Fusion System, a Intervertebral Fusion Device With Integrated Fixation, Cervical (Class II — Special Controls, product code OVE), submitted by MiRus, LLC (Marietta, US). The FDA issued a Cleared decision on October 27, 2023, 81 days after receiving the submission on August 7, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K232348 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 07, 2023
Decision Date	October 27, 2023
Days to Decision	81 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	OVE — Intervertebral Fusion Device With Integrated Fixation, Cervical
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3080
Definition	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.