510(k) K232154

MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate Fixation by MiRus, LLC — Product Code OVD

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: September 11, 2023
Date Received: July 20, 2023
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

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

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.

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