FDA 510(k)

Implant-One 系统

K号: K231455 · 2023-08-15

决定日期2023-08-15

产品代码NHA

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决定实质等同

器械摘要

Implant-One System is the device name listed in this FDA 510(k) record. The listed applicant is Implant Logistics, Inc.. It received FDA 510(k) clearance on 2023-08-15 under 510(k) number K231455. 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 Implant-One System?

Implant-One System is a medical device that received FDA 510(k) clearance on 2023-08-15. The listed applicant is Implant Logistics, Inc.. The 510(k) number is K231455.

When did Implant-One System receive FDA 510(k) clearance?

Implant-One System received FDA 510(k) clearance on 2023-08-15, under 510(k) number K231455.

Who is the listed applicant for Implant-One System?

The FDA 510(k) record lists Implant Logistics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Implant-One System?

The FDA product code for Implant-One System is NHA.

列明Implant Logistics, 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。

K212394Implant-One 多单元基台 K173701Implant-One 系统

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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官方来源

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