FDA 510(k)

德普艾克提斯杜烏福髋關節置換術

K 號：K160907 · 2016-07-19

決定日期2016-07-19

產品代碼MEH

諮詢委員會或

決定相當於

器材摘要

DePuy Actis DuoFix Hip Prosthesis is the device name listed in this FDA 510(k) record. The listed applicant is Depuy(Ireland). It received FDA 510(k) clearance on 2016-07-19 under 510(k) number K160907. The device is classified under product code MEH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the DePuy Actis DuoFix Hip Prosthesis?

DePuy Actis DuoFix Hip Prosthesis is a medical device that received FDA 510(k) clearance on 2016-07-19. The listed applicant is Depuy(Ireland). The 510(k) number is K160907.

When did DePuy Actis DuoFix Hip Prosthesis receive FDA 510(k) clearance?

DePuy Actis DuoFix Hip Prosthesis received FDA 510(k) clearance on 2016-07-19, under 510(k) number K160907.

Who is the listed applicant for DePuy Actis DuoFix Hip Prosthesis?

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

What is the FDA product code for DePuy Actis DuoFix Hip Prosthesis?

The FDA product code for DePuy Actis DuoFix Hip Prosthesis is MEH.

其他以 Depuy(Ireland) 為申請人之記錄

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相關器械（代碼：MEH）

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。

K261576象納髋關節置入體Corin, Ltd.K250375Allure骨盆柄和骨髓內插釘Waldemar Link GmbH & Co. KG K251166Mfinity 髋關系統Medacta International S.A.K251052Trivicta® 髋關節柄Ortho Development Corp.K242315解決模組化修復股骨柄United Orthopedic Corporation K243839Alteon® HA Femoral StemsExactech, Inc.

官方來源

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