FDA 510(k)

Mazor X 系統（Mazor X 隱形版）

K 號：K182077 · 2018-11-02

決定日期2018-11-02

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

Mazor X System (Mazor X Stealth Edition) is the device name listed in this FDA 510(k) record. The listed applicant is Mazor Robotics , Ltd.. It received FDA 510(k) clearance on 2018-11-02 under 510(k) number K182077. 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 Mazor X System (Mazor X Stealth Edition)?

Mazor X System (Mazor X Stealth Edition) is a medical device that received FDA 510(k) clearance on 2018-11-02. The listed applicant is Mazor Robotics , Ltd.. The 510(k) number is K182077.

When did Mazor X System (Mazor X Stealth Edition) receive FDA 510(k) clearance?

Mazor X System (Mazor X Stealth Edition) received FDA 510(k) clearance on 2018-11-02, under 510(k) number K182077.

Who is the listed applicant for Mazor X System (Mazor X Stealth Edition)?

The FDA 510(k) record lists Mazor Robotics , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Mazor X System (Mazor X Stealth Edition)?

The FDA product code for Mazor X System (Mazor X Stealth Edition) is OLO.

其他以 Mazor Robotics , Ltd. 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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