FDA 510(k)

Mako全髋關節應用，Mako全膝關節應用

K 號：K191998 · 2019-09-24

決定日期2019-09-24

產品代碼OLO

諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)

決定相當於

器材摘要

Mako Total Hip Application, Mako Total Knee Application is the device name listed in this FDA 510(k) record. The listed applicant is Mako Surgical Corp.. It received FDA 510(k) clearance on 2019-09-24 under 510(k) number K191998. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Mako Total Hip Application, Mako Total Knee Application?

Mako Total Hip Application, Mako Total Knee Application is a medical device that received FDA 510(k) clearance on 2019-09-24. The listed applicant is Mako Surgical Corp.. The 510(k) number is K191998.

When did Mako Total Hip Application, Mako Total Knee Application receive FDA 510(k) clearance?

Mako Total Hip Application, Mako Total Knee Application received FDA 510(k) clearance on 2019-09-24, under 510(k) number K191998.

Who is the listed applicant for Mako Total Hip Application, Mako Total Knee Application?

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

What is the FDA product code for Mako Total Hip Application, Mako Total Knee Application?

The FDA product code for Mako Total Hip Application, Mako Total Knee Application is OLO.

其他以 Mako Surgical Corp. 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。

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相關器械（代碼：OLO）

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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官方來源

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