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FDA 510(k)

AERO MIS Facet Fusion System

K-Number: K243865 · 2025-03-24

ApplicantAurora Spine
Decision Date2025-03-24
Product CodeMRW
DecisionSubstantially Equivalent

Device Summary

AERO MIS Facet Fusion System is the device name listed in this FDA 510(k) record. The listed applicant is Aurora Spine. It received FDA 510(k) clearance on 2025-03-24 under 510(k) number K243865. The device is classified under product code MRW. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AERO MIS Facet Fusion System?

AERO MIS Facet Fusion System is a medical device that received FDA 510(k) clearance on 2025-03-24. The listed applicant is Aurora Spine. The 510(k) number is K243865.

When did AERO MIS Facet Fusion System receive FDA 510(k) clearance?

AERO MIS Facet Fusion System received FDA 510(k) clearance on 2025-03-24, under 510(k) number K243865.

Who is the listed applicant for AERO MIS Facet Fusion System?

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

What is the FDA product code for AERO MIS Facet Fusion System?

The FDA product code for AERO MIS Facet Fusion System is MRW.

Other records listing Aurora Spine 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.

K221047SILO TFX MIS Sacroiliac Joint Fixation SystemK221399ZIP™ MIS Interspinous Fusion SystemK220610SOLO-LK210521DEXA-C Cervical Interbody SystemK210325APOLLO Anterior Cervical Plate (ACP) System

Related Devices (Code: MRW)

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.

K261209Ion-LSurGenTec, LLCK253676CORUS™ Posterior Cervical Stabilization System 3D (CORUS™ PCSS 3D)Providence Medical Technology, Inc.K253432DiversiVy™ Facet Screw SystemVy Spine, LLCK251714Ion-CSurGenTec, LLCK250679FFX Facet Fixation SystemSc MedicaK253190CORUS-LX ImplantProvidence Medical Technology, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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