FDA 510(k)

内部六角植入系统

K号: K190837 · 2020-01-22

决定日期2020-01-22

产品代码DZE

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决定实质等同

器械摘要

Internal Hex Implant System is the device name listed in this FDA 510(k) record. The listed applicant is Ebi, Inc.. It received FDA 510(k) clearance on 2020-01-22 under 510(k) number K190837. 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 Internal Hex Implant System?

Internal Hex Implant System is a medical device that received FDA 510(k) clearance on 2020-01-22. The listed applicant is Ebi, Inc.. The 510(k) number is K190837.

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

Internal Hex Implant System received FDA 510(k) clearance on 2020-01-22, under 510(k) number K190837.

Who is the listed applicant for Internal Hex Implant System?

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

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

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

列明Ebi, 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。

K170031内部八角植入系统

官方来源

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