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FDA 510(k)

Distal Radius Plating System

K-Number: K161292 · 2016-08-15

ApplicantMiami Device Solutions, LLC
Decision Date2016-08-15
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Distal Radius Plating System is the device name listed in this FDA 510(k) record. The listed applicant is Miami Device Solutions, LLC. It received FDA 510(k) clearance on 2016-08-15 under 510(k) number K161292. 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 Distal Radius Plating System?

Distal Radius Plating System is a medical device that received FDA 510(k) clearance on 2016-08-15. The listed applicant is Miami Device Solutions, LLC. The 510(k) number is K161292.

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

Distal Radius Plating System received FDA 510(k) clearance on 2016-08-15, under 510(k) number K161292.

Who is the listed applicant for Distal Radius Plating System?

The FDA 510(k) record lists Miami Device Solutions, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Distal Radius Plating System?

The FDA product code for Distal Radius Plating System is HRS.

Other records listing Miami Device Solutions, LLC as applicant

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.

K182810Distal Radius Plating SystemK172786MDS Plating SystemK162898Olecranon Plating SystemK162635Distal Radius Plating SystemK161058Cannulated Screw

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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