FDA 510(k)

Anthogyr AXIOM® BL X3植入物，Anthogyr Multi-Unit组件用于AXIOM® BL

K号: K230104 · 2023-10-16

决定日期2023-10-16

产品代码DZE

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决定实质等同

器械摘要

Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for AXIOM® BL is the device name listed in this FDA 510(k) record. The listed applicant is Anthogyr. It received FDA 510(k) clearance on 2023-10-16 under 510(k) number K230104. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for AXIOM® BL?

Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for AXIOM® BL is a medical device that received FDA 510(k) clearance on 2023-10-16. The listed applicant is Anthogyr. The 510(k) number is K230104.

When did Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for AXIOM® BL receive FDA 510(k) clearance?

Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for AXIOM® BL received FDA 510(k) clearance on 2023-10-16, under 510(k) number K230104.

Who is the listed applicant for Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for AXIOM® BL?

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 AXIOM® BL X3 implants, Anthogyr Multi-Unit components for AXIOM® BL?

The FDA product code for Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for AXIOM® BL is DZE.

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 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。