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FDA 510(k)

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

K 號：K260353 · 2026-03-03

申請人Arthrex, Inc.
決定日期2026-03-03
產品代碼HRS
諮詢委員會OR
決定Substantially Equivalent

器材摘要

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.

常見問題

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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相關器械（代碼：HRS）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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