FDA 510(k)

齊默髋關節置換設備

K 號：K200112 · 2020-04-10

決定日期2020-04-10

產品代碼LZO

諮詢委員會或

決定相當於

器材摘要

Zimmer Hip Joint Replacement is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer GmbH. It received FDA 510(k) clearance on 2020-04-10 under 510(k) number K200112. 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 Zimmer Hip Joint Replacement?

Zimmer Hip Joint Replacement is a medical device that received FDA 510(k) clearance on 2020-04-10. The listed applicant is Zimmer GmbH. The 510(k) number is K200112.

When did Zimmer Hip Joint Replacement receive FDA 510(k) clearance?

Zimmer Hip Joint Replacement received FDA 510(k) clearance on 2020-04-10, under 510(k) number K200112.

Who is the listed applicant for Zimmer Hip Joint Replacement?

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 Zimmer Hip Joint Replacement?

The FDA product code for Zimmer Hip Joint Replacement 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。

K260173M-Vizion 髋關節更換系統擴充版Medacta International S.A.K253948動力骨盂杯系統United Orthopedic Corporation K261009MobileLink 骨盆杯系統 – 40mm ID 插片（各種）Waldemar Link GmbH & Co. KG K260831Z1 髋關節系統Zimmer, Inc.K260182Avenir® Müller 植入物；Avenir Complete™ 髋關節系統Zimmer, Inc.K260037植入式醫療設備包裝系統更新Implantcast GmbH

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