FDA 510(k)

解剖肩部Domelock Dome中心設置

K 號：K161620 · 2016-11-01

決定日期2016-11-01

產品代碼HSD

諮詢委員會或

決定相當於

器材摘要

Anatomical Shoulder Domelock Dome centric is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer GmbH. It received FDA 510(k) clearance on 2016-11-01 under 510(k) number K161620. 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 Anatomical Shoulder Domelock Dome centric?

Anatomical Shoulder Domelock Dome centric is a medical device that received FDA 510(k) clearance on 2016-11-01. The listed applicant is Zimmer GmbH. The 510(k) number is K161620.

When did Anatomical Shoulder Domelock Dome centric receive FDA 510(k) clearance?

Anatomical Shoulder Domelock Dome centric received FDA 510(k) clearance on 2016-11-01, under 510(k) number K161620.

Who is the listed applicant for Anatomical Shoulder Domelock Dome centric?

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

What is the FDA product code for Anatomical Shoulder Domelock Dome centric?

The FDA product code for Anatomical Shoulder Domelock Dome centric is HSD.

其他以 Zimmer GmbH 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。

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.K161782Arthrex Univers Revers Shoulder Prosthesis SystemArthrex, Inc.

官方來源

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