FDA 510(k)

Anthogyr INTEGRAL引导手术盒

K号: K233264 · 2023-12-22

决定日期2023-12-22

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

Anthogyr INTEGRAL Guided Surgery Cassettes is the device name listed in this FDA 510(k) record. The listed applicant is Anthogyr. It received FDA 510(k) clearance on 2023-12-22 under 510(k) number K233264. 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 Anthogyr INTEGRAL Guided Surgery Cassettes?

Anthogyr INTEGRAL Guided Surgery Cassettes is a medical device that received FDA 510(k) clearance on 2023-12-22. The listed applicant is Anthogyr. The 510(k) number is K233264.

When did Anthogyr INTEGRAL Guided Surgery Cassettes receive FDA 510(k) clearance?

Anthogyr INTEGRAL Guided Surgery Cassettes received FDA 510(k) clearance on 2023-12-22, under 510(k) number K233264.

Who is the listed applicant for Anthogyr INTEGRAL Guided Surgery Cassettes?

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 Anthogyr INTEGRAL Guided Surgery Cassettes?

The FDA product code for Anthogyr INTEGRAL Guided Surgery Cassettes 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 K230104Anthogyr AXIOM® BL X3植入物，Anthogyr Multi-Unit组件用于AXIOM® BL K230680Anthogyr手术盒 K160730Instrument kits

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。