ATLAS Plating System
K-Number: K190415 · 2019-04-19
ApplicantMiRus, LLC
Decision Date2019-04-19
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 2019-04-19 under approval number K190415. 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 2019-04-19. It is manufactured by MiRus, LLC. The 510(k) number is K190415.
When was ATLAS Plating System approved by the FDA?
ATLAS Plating System received FDA 510(k) clearance on 2019-04-19, under approval number K190415.
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.