ATLAS Plating System
K-Number: K191867 · 2020-04-09
ApplicantMiRus, LLC
Decision Date2020-04-09
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
ATLAS Plating System is a medical device manufactured by MiRus, LLC. It received FDA 510(k) clearance on 2020-04-09 under approval number K191867. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the ATLAS Plating System?
ATLAS Plating System is a medical device that received FDA 510(k) clearance on 2020-04-09. It is manufactured by MiRus, LLC. The 510(k) number is K191867.
When was ATLAS Plating System approved by the FDA?
ATLAS Plating System received FDA 510(k) clearance on 2020-04-09, under approval number K191867.
What company makes ATLAS Plating System?
ATLAS Plating System is manufactured by MiRus, LLC.
What is the FDA product code for ATLAS Plating System?
The FDA product code for ATLAS Plating System is HRS.
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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.