FDA 510(k)

ST 内部植入系统

K号: K190919 · 2020-02-27

决定日期2020-02-27

产品代码DZE

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决定实质等同

器械摘要

ST Internal Implant System is the device name listed in this FDA 510(k) record. The listed applicant is T-Plus Implant Tech. Co., Ltd.. It received FDA 510(k) clearance on 2020-02-27 under 510(k) number K190919. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the ST Internal Implant System?

ST Internal Implant System is a medical device that received FDA 510(k) clearance on 2020-02-27. The listed applicant is T-Plus Implant Tech. Co., Ltd.. The 510(k) number is K190919.

When did ST Internal Implant System receive FDA 510(k) clearance?

ST Internal Implant System received FDA 510(k) clearance on 2020-02-27, under 510(k) number K190919.

Who is the listed applicant for ST Internal Implant System?

The FDA 510(k) record lists T-Plus Implant Tech. Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ST Internal Implant System?

The FDA product code for ST Internal Implant System is DZE.

列明T-Plus Implant Tech. Co., Ltd.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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