FDA 510(k)

Mazor X 系統 / Mazor X 隱形版

K 號：K251316 · 2025-09-11

決定日期2025-09-11

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 2025-09-11 under 510(k) number K251316. 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 2025-09-11. The listed applicant is Mazor Robotics , Ltd.. The 510(k) number is K251316.

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 2025-09-11, under 510(k) number K251316.

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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官方來源

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