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 a medical device manufactured by MiRus, LLC. It received FDA 510(k) clearance on 2018-12-18 under approval 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. It is manufactured by MiRus, LLC. The 510(k) number is K182989.
When was AURORA Screw System approved by the FDA?
AURORA Screw System received FDA 510(k) clearance on 2018-12-18, under approval number K182989.
What company makes AURORA Screw System?
AURORA Screw System is manufactured by MiRus, LLC.
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.
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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.