FDA 510(k)

高保留连接系统

K号: K213391 · 2022-01-11

决定日期2022-01-11

产品代码NHA

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决定实质等同

器械摘要

High Retention Attachment System is the device name listed in this FDA 510(k) record. The listed applicant is Zest Anchors, LLC. It received FDA 510(k) clearance on 2022-01-11 under 510(k) number K213391. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the High Retention Attachment System?

High Retention Attachment System is a medical device that received FDA 510(k) clearance on 2022-01-11. The listed applicant is Zest Anchors, LLC. The 510(k) number is K213391.

When did High Retention Attachment System receive FDA 510(k) clearance?

High Retention Attachment System received FDA 510(k) clearance on 2022-01-11, under 510(k) number K213391.

Who is the listed applicant for High Retention Attachment System?

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

What is the FDA product code for High Retention Attachment System?

The FDA product code for High Retention Attachment System is NHA.

列明Zest Anchors, 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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相关器械（代码：NHA）

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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