MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate Fixation
K-Number: K232154 · 2023-09-11
ApplicantMiRus, LLC
Decision Date2023-09-11
Product CodeOVD
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate Fixation is a medical device manufactured by MiRus, LLC. It received FDA 510(k) clearance on 2023-09-11 under approval number K232154. The device is classified under product code OVD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate Fixation?
MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate Fixation is a medical device that received FDA 510(k) clearance on 2023-09-11. It is manufactured by MiRus, LLC. The 510(k) number is K232154.
When was MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate Fixation approved by the FDA?
MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate Fixation received FDA 510(k) clearance on 2023-09-11, under approval number K232154.
What company makes MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate Fixation?
MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate Fixation is manufactured by MiRus, LLC.
What is the FDA product code for MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate Fixation?
The FDA product code for MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate Fixation is OVD.
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Related PubMed Literature
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.