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FDA 510(k)

PTG-05

K号: K240347 · 2024-07-21

决定日期2024-07-21
产品代码NGX
咨询委员会PM 请注意,由于您没有提供具体的医疗设备监管文本,我无法进行翻译。请提供具体的文本内容,以便我能够按照您的要求进行翻译。
决定实质等同

器械摘要

PTG-05 is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer Medizinsysteme GmbH. It received FDA 510(k) clearance on 2024-07-21 under 510(k) number K240347. The device is classified under product code NGX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the PTG-05?

PTG-05 is a medical device that received FDA 510(k) clearance on 2024-07-21. The listed applicant is Zimmer Medizinsysteme GmbH. The 510(k) number is K240347.

When did PTG-05 receive FDA 510(k) clearance?

PTG-05 received FDA 510(k) clearance on 2024-07-21, under 510(k) number K240347.

Who is the listed applicant for PTG-05?

The FDA 510(k) record lists Zimmer Medizinsysteme GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PTG-05?

The FDA product code for PTG-05 is NGX.

列明Zimmer Medizinsysteme GmbH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。

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相关器械(代码:NGX)

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。

官方来源

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