FDA 510(k)

Avenir Muller 植入物，Avenir 粘合固定髋關節植入物

K 號：K193030 · 2019-12-06

決定日期2019-12-06

產品代碼LZO

諮詢委員會或

決定相當於

器材摘要

Avenir Muller Stem, Avenir Cemented Hip Stem is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer GmbH. It received FDA 510(k) clearance on 2019-12-06 under 510(k) number K193030. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Avenir Muller Stem, Avenir Cemented Hip Stem?

Avenir Muller Stem, Avenir Cemented Hip Stem is a medical device that received FDA 510(k) clearance on 2019-12-06. The listed applicant is Zimmer GmbH. The 510(k) number is K193030.

When did Avenir Muller Stem, Avenir Cemented Hip Stem receive FDA 510(k) clearance?

Avenir Muller Stem, Avenir Cemented Hip Stem received FDA 510(k) clearance on 2019-12-06, under 510(k) number K193030.

Who is the listed applicant for Avenir Muller Stem, Avenir Cemented Hip Stem?

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 Avenir Muller Stem, Avenir Cemented Hip Stem?

The FDA product code for Avenir Muller Stem, Avenir Cemented Hip Stem is LZO.

其他以 Zimmer GmbH 為申請人之記錄

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相關器械（代碼：LZO）

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。

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