FDA 510(k)

DeGen 导航工具

K号: K213918 · 2022-02-09

决定日期2022-02-09

产品代码OLO

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决定实质等同

器械摘要

DeGen Navigated Instrumentation is the device name listed in this FDA 510(k) record. The listed applicant is Degen Medical. It received FDA 510(k) clearance on 2022-02-09 under 510(k) number K213918. 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 DeGen Navigated Instrumentation?

DeGen Navigated Instrumentation is a medical device that received FDA 510(k) clearance on 2022-02-09. The listed applicant is Degen Medical. The 510(k) number is K213918.

When did DeGen Navigated Instrumentation receive FDA 510(k) clearance?

DeGen Navigated Instrumentation received FDA 510(k) clearance on 2022-02-09, under 510(k) number K213918.

Who is the listed applicant for DeGen Navigated Instrumentation?

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

What is the FDA product code for DeGen Navigated Instrumentation?

The FDA product code for DeGen Navigated Instrumentation is OLO.

列明Degen Medical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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官方来源

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