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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is MiRus, LLC. It received FDA 510(k) clearance on 2020-04-09 under 510(k) 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. The listed applicant is MiRus, LLC. The 510(k) number is K191867.

When did ATLAS Plating System receive FDA 510(k) clearance?

ATLAS Plating System received FDA 510(k) clearance on 2020-04-09, under 510(k) number K191867.

Who is the listed applicant for ATLAS Plating 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 ATLAS Plating System?

The FDA product code for ATLAS Plating System is HRS.

Other records listing MiRus, LLC as applicant

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Related Devices (Code: HRS)

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.

K260277MIKRON TRAUMA BONE PLATE& SCREW SYSTEMMikron Makina San. ve Tic. Ltd. Sti.K261511Xpert AnkleNewclip TechnicsK261406Versalock Proximal Tibial Plating SystemGM Dos Reis Industria e Comercio Ltda.K262032TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFR-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFL-SHB );TriMed Non-Spanning Wrist Fusion Plates (NSFR-SHB )TriMed, Inc.K261191Alians Elbow SNewclip TechnicsK261054RibPlate SystemStryker Leibinger GmbH & Co KG

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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