FDA 510(k)

Arthrex Univers Revers Shoulder Prosthesis System

K 號：K161782 · 2016-11-21

決定日期2016-11-21

產品代碼HSD

諮詢委員會或

決定相當於

器材摘要

Arthrex Univers Revers Shoulder Prosthesis System is the device name listed in this FDA 510(k) record. The listed applicant is Arthrex, Inc.. It received FDA 510(k) clearance on 2016-11-21 under 510(k) number K161782. 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 Arthrex Univers Revers Shoulder Prosthesis System?

Arthrex Univers Revers Shoulder Prosthesis System is a medical device that received FDA 510(k) clearance on 2016-11-21. The listed applicant is Arthrex, Inc.. The 510(k) number is K161782.

When did Arthrex Univers Revers Shoulder Prosthesis System receive FDA 510(k) clearance?

Arthrex Univers Revers Shoulder Prosthesis System received FDA 510(k) clearance on 2016-11-21, under 510(k) number K161782.

Who is the listed applicant for Arthrex Univers Revers Shoulder Prosthesis System?

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 Arthrex Univers Revers Shoulder Prosthesis System?

The FDA product code for Arthrex Univers Revers Shoulder Prosthesis System is HSD.

其他以 Arthrex, Inc. 為申請人之記錄

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。

K262975Arthrex Beaming系統 K262618Arthrex 腰椎壓縮 FT 螺釘 K262451Arthrex DynaNite 针 K262357Arthrex 生物可吸收式 PushLock 縫線釘 K260624Arthrex 放射性頭替換系統 K260018Arthrex FiberButton

查看所有 176 項裝置 →

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。

K233260Univers Revers CA 頭與轉接器Arthrex, Inc.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.K161620解剖肩部Domelock Dome中心設置Zimmer GmbH

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。