FDA 510(k)

Univers Revers CA 頭與轉接器

K 號：K233260 · 2024-02-12

決定日期2024-02-12

產品代碼HSD

諮詢委員會或

決定相當於

器材摘要

Univers Revers CA Head and Adapter is the device name listed in this FDA 510(k) record. The listed applicant is Arthrex, Inc.. It received FDA 510(k) clearance on 2024-02-12 under 510(k) number K233260. The device is classified under product code HSD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Univers Revers CA Head and Adapter?

Univers Revers CA Head and Adapter is a medical device that received FDA 510(k) clearance on 2024-02-12. The listed applicant is Arthrex, Inc.. The 510(k) number is K233260.

When did Univers Revers CA Head and Adapter receive FDA 510(k) clearance?

Univers Revers CA Head and Adapter received FDA 510(k) clearance on 2024-02-12, under 510(k) number K233260.

Who is the listed applicant for Univers Revers CA Head and Adapter?

FDA 510(k) 記錄將 Arthrex, Inc. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Univers Revers CA Head and Adapter?

The FDA product code for Univers Revers CA Head and Adapter is HSD.

其他以 Arthrex, Inc. 為申請人之記錄

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相關器械（代碼：HSD）

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。

K221232大學反向上臂杯植入體Arthrex, Inc.K191433AGILON® XO肩部置換系統Implantcast GmbH K193122Biocore9 肱骨表面修復系統Biocore9, LLC K173964OVOMotion 肩關節置換系統Arthrosurface, Inc.K161782Arthrex Univers Revers Shoulder Prosthesis SystemArthrex, Inc.K161620解剖肩部Domelock Dome中心設置Zimmer GmbH

官方來源

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