Cleared Traditional

MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate Fixation

K232154 · MiRus, LLC · Orthopedic

Sep 2023

Decision

53d

Days

Class 2

Risk

About This 510(k) Submission

K232154 is an FDA 510(k) clearance for the MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate Fixation, a Intervertebral Fusion Device With Integrated Fixation, Lumbar (Class II — Special Controls, product code OVD), submitted by MiRus, LLC (Marietta, US). The FDA issued a Cleared decision on September 11, 2023, 53 days after receiving the submission on July 20, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K232154 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 20, 2023
Decision Date	September 11, 2023
Days to Decision	53 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	OVD — Intervertebral Fusion Device With Integrated Fixation, Lumbar
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3080
Definition	Intended To Stabilize Lumbar Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft With Or Without Supplemental Fixation.