FDA 510(k)

Mazor X系统 / Mazor X隐形版

K号: K251316 · 2025-09-11

决定日期2025-09-11

产品代码OLO

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决定实质等同

器械摘要

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.

常见问题

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.

列明Mazor Robotics , Ltd.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K230064Mazor X系统（Mazor X隐形版）K203005Mazor X K200935Mazor X K182077Mazor X系统（Mazor X隐形版）K180307Mazor X K172522Mazor X

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官方来源

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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。