FDA 510(k)

Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage Button

Número K: K260353 · 2026-03-03

Data da decisão2026-03-03

Código do produtoHRS

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage Button is the device name listed in this FDA 510(k) record. The listed applicant is Arthrex, Inc.. It received FDA 510(k) clearance on 2026-03-03 under 510(k) number K260353. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage Button?

Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage Button is a medical device that received FDA 510(k) clearance on 2026-03-03. The listed applicant is Arthrex, Inc.. The 510(k) number is K260353.

When did Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage Button receive FDA 510(k) clearance?

Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage Button received FDA 510(k) clearance on 2026-03-03, under 510(k) number K260353.

Who is the listed applicant for Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage Button?

The FDA 510(k) record lists Arthrex, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage Button?

The FDA product code for Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage Button is HRS.

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Fonte oficial

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