FDA 510(k)

Harvey(R)外科助手

K号: K200892 · 2020-06-18

决定日期2020-06-18

产品代码OLO

咨询委员会NE 请注意，您提供的文本“NE”不足以进行翻译，因为它不是一个完整的句子或描述。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。

决定实质等同

器械摘要

Harvey(R) Surgical Assistant is the device name listed in this FDA 510(k) record. The listed applicant is Orthalign, Inc.. It received FDA 510(k) clearance on 2020-06-18 under 510(k) number K200892. 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 Harvey(R) Surgical Assistant?

Harvey(R) Surgical Assistant is a medical device that received FDA 510(k) clearance on 2020-06-18. The listed applicant is Orthalign, Inc.. The 510(k) number is K200892.

When did Harvey(R) Surgical Assistant receive FDA 510(k) clearance?

Harvey(R) Surgical Assistant received FDA 510(k) clearance on 2020-06-18, under 510(k) number K200892.

Who is the listed applicant for Harvey(R) Surgical Assistant?

FDA 510(k)记录中列出Orthalign, Inc.为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for Harvey(R) Surgical Assistant?

The FDA product code for Harvey(R) Surgical Assistant is OLO.

列明Orthalign, Inc.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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