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FDA 510(k)

AURORA™ Screw System

K-Number: K182989 · 2018-12-18

ApplicantMiRus, LLC
Decision Date2018-12-18
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

AURORA™ Screw System is the device name listed in this FDA 510(k) record. The listed applicant is MiRus, LLC. It received FDA 510(k) clearance on 2018-12-18 under 510(k) number K182989. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AURORA™ Screw System?

AURORA™ Screw System is a medical device that received FDA 510(k) clearance on 2018-12-18. The listed applicant is MiRus, LLC. The 510(k) number is K182989.

When did AURORA™ Screw System receive FDA 510(k) clearance?

AURORA™ Screw System received FDA 510(k) clearance on 2018-12-18, under 510(k) number K182989.

Who is the listed applicant for AURORA™ Screw System?

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 AURORA™ Screw System?

The FDA product code for AURORA™ Screw System is HWC. This falls under the Cardiovascular category.

Other records listing MiRus, LLC as applicant

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Related Devices (Code: HWC)

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.

K262344Large Compression ScrewsTriMed, Inc.K253858GFS - Sterile Screws and Top HatT.A.G. Medical Products Corporation, Ltd.K262075Lapidus Screw KitRelja Innovations, LLCK260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.K253108VEOFIX Snap Off ScrewSteps OrthoK261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC

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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