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FDA 510(k)

Delphos Implants Rigid Fixation System

K号: K182609 · 2019-03-29

申请人Delphos Implants - Ind.Com. Importacao E Exportacao DE
决定日期2019-03-29
产品代码JEY
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决定实质等同

器械摘要

Delphos Implants Rigid Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Delphos Implants - Ind.Com. Importacao E Exportacao DE. It received FDA 510(k) clearance on 2019-03-29 under 510(k) number K182609. The device is classified under product code JEY. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Delphos Implants Rigid Fixation System?

Delphos Implants Rigid Fixation System is a medical device that received FDA 510(k) clearance on 2019-03-29. The listed applicant is Delphos Implants - Ind.Com. Importacao E Exportacao DE. The 510(k) number is K182609.

When did Delphos Implants Rigid Fixation System receive FDA 510(k) clearance?

Delphos Implants Rigid Fixation System received FDA 510(k) clearance on 2019-03-29, under 510(k) number K182609.

Who is the listed applicant for Delphos Implants Rigid Fixation System?

The FDA 510(k) record lists Delphos Implants - Ind.Com. Importacao E Exportacao DE as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Delphos Implants Rigid Fixation System?

The FDA product code for Delphos Implants Rigid Fixation System is JEY.

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相关器械（代码：JEY）

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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