FDA 510(k)

Longeviti PorousFit 植入物

K号: K211514 · 2021-07-15

决定日期2021-07-15

产品代码KKY

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决定实质等同

器械摘要

Longeviti PorousFit implant is the device name listed in this FDA 510(k) record. The listed applicant is Longeviti Neuro Solutions, LLC. It received FDA 510(k) clearance on 2021-07-15 under 510(k) number K211514. The device is classified under product code KKY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Longeviti PorousFit implant?

Longeviti PorousFit implant is a medical device that received FDA 510(k) clearance on 2021-07-15. The listed applicant is Longeviti Neuro Solutions, LLC. The 510(k) number is K211514.

When did Longeviti PorousFit implant receive FDA 510(k) clearance?

Longeviti PorousFit implant received FDA 510(k) clearance on 2021-07-15, under 510(k) number K211514.

Who is the listed applicant for Longeviti PorousFit implant?

The FDA 510(k) record lists Longeviti Neuro Solutions, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Longeviti PorousFit implant?

The FDA product code for Longeviti PorousFit implant is KKY.

列明Longeviti Neuro Solutions, LLC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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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。