FDA 510(k)

Estar-ZE

K号: K242521 · 2024-11-20

决定日期2024-11-20

产品代码EIH

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决定实质等同

器械摘要

Estar-ZE is the device name listed in this FDA 510(k) record. The listed applicant is Osstem Implant Co., Ltd.. It received FDA 510(k) clearance on 2024-11-20 under 510(k) number K242521. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Estar-ZE?

Estar-ZE is a medical device that received FDA 510(k) clearance on 2024-11-20. The listed applicant is Osstem Implant Co., Ltd.. The 510(k) number is K242521.

When did Estar-ZE receive FDA 510(k) clearance?

Estar-ZE received FDA 510(k) clearance on 2024-11-20, under 510(k) number K242521.

Who is the listed applicant for Estar-ZE?

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

What is the FDA product code for Estar-ZE?

The FDA product code for Estar-ZE is EIH.

列明Osstem Implant 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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