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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is MiRus, LLC. It received FDA 510(k) clearance on 2023-09-11 under 510(k) 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. The listed applicant is MiRus, LLC. The 510(k) number is K232154.

When did MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate Fixation receive FDA 510(k) clearance?

MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate Fixation received FDA 510(k) clearance on 2023-09-11, under 510(k) number K232154.

Who is the listed applicant for MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate Fixation?

The FDA 510(k) record lists MiRus, LLC as the applicant. This does not by itself establish the device manufacturer.

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.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT05762055Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative TechnologyENROLLING_BY_INVITATIONNCT06904898CONDUIT vs. PEEK CagesACTIVE_NOT_RECRUITINGNCT07222787Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion OutcomesRECRUITINGNCT048238583Spine Lumbar Fusion Real World Evidence StudyACTIVE_NOT_RECRUITINGNCT05237908Clinical Outcome and Fusion Rate of 3D Printed Interbody Fusion Cages and Titanium Coated PEEK CagesACTIVE_NOT_RECRUITINGNCT05438719MOTUS Total Joint Replacement Investigational Device Exemption StudyACTIVE_NOT_RECRUITING

Other records listing MiRus, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253444EUROPA™ Posterior Cervical Fusion Navigated InstrumentsK252733ATLAS™ Expandable Osteotomy Wedge SystemK242516EUROPA™ Posterior Cervical Fusion SystemK241175MiRus MoRe Lumbar Plating SystemK232348RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion SystemK232481RIGEL™ 3DR Anterior Cervical Corpectomy System

View all 24 devices →

Related Devices (Code: OVD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261408SABER-XA SystemElevation SpineK261809Interwedge® Standalone LateralFoundation Surgical GroupK261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor SystemKyocera Medical Technologies, Inc.K260810Anteralign LS coverplateTyber Medical, LLCK254202MectaLIF 3D Metal AnteriorMedacta International S.A.K253401SCRIPT™ Implant SystemGlobus Medical, Inc.

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.

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