FDA 510(k)

Instrument kits

K号: K160730 · 2017-04-27

决定日期2017-04-27

产品代码KCT

咨询委员会医疗设备监管文本翻译如下： HO 请注意，由于您没有提供具体的医疗设备监管文本内容，以上仅为示例。请提供具体的文本内容以便进行准确的翻译。

决定实质等同

器械摘要

Instrument kits is the device name listed in this FDA 510(k) record. The listed applicant is Anthogyr. It received FDA 510(k) clearance on 2017-04-27 under 510(k) number K160730. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Instrument kits?

Instrument kits is a medical device that received FDA 510(k) clearance on 2017-04-27. The listed applicant is Anthogyr. The 510(k) number is K160730.

When did Instrument kits receive FDA 510(k) clearance?

Instrument kits received FDA 510(k) clearance on 2017-04-27, under 510(k) number K160730.

Who is the listed applicant for Instrument kits?

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

What is the FDA product code for Instrument kits?

The FDA product code for Instrument kits is KCT.

列明Anthogyr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。

K231072Anthogyr FlexiBase®钛基座用于Axiom® BL K233264Anthogyr INTEGRAL引导手术盒 K230104Anthogyr AXIOM® BL X3植入物，Anthogyr Multi-Unit组件用于AXIOM® BL K230680Anthogyr手术盒

官方来源

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