FDA 510(k)

齊默Nexel全肘，康拉德/莫雷全肘

K 號：K181307 · 2019-01-28

決定日期2019-01-28

產品代碼JDC

諮詢委員會或

決定相當於

器材摘要

Zimmer Nexel Total Elbow, Connrad/Morrey Total Elbow is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer, Inc.. It received FDA 510(k) clearance on 2019-01-28 under 510(k) number K181307. The device is classified under product code JDC. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Zimmer Nexel Total Elbow, Connrad/Morrey Total Elbow?

Zimmer Nexel Total Elbow, Connrad/Morrey Total Elbow is a medical device that received FDA 510(k) clearance on 2019-01-28. The listed applicant is Zimmer, Inc.. The 510(k) number is K181307.

When did Zimmer Nexel Total Elbow, Connrad/Morrey Total Elbow receive FDA 510(k) clearance?

Zimmer Nexel Total Elbow, Connrad/Morrey Total Elbow received FDA 510(k) clearance on 2019-01-28, under 510(k) number K181307.

Who is the listed applicant for Zimmer Nexel Total Elbow, Connrad/Morrey Total Elbow?

FDA 510(k) 記錄將 Zimmer, 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 Zimmer Nexel Total Elbow, Connrad/Morrey Total Elbow?

The FDA product code for Zimmer Nexel Total Elbow, Connrad/Morrey Total Elbow is JDC.

其他以 Zimmer, Inc. 為申請人之記錄

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相關器械（代碼：JDC）

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。

K181362TEMA 肘關節系統Lima Corporate S.P.A.K153398綜合SRS/Nexel手肘Biomet Manufacturing Corp

官方來源

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