FDA 510(k)

德菲斯植入物刚性固定系統

K 號：K182609 · 2019-03-29

申請人Delphos Implants - Ind.Com. Importacao E Exportacao DE

決定日期2019-03-29

產品代碼JEY

諮詢委員會DE

決定相當於

器材摘要

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.

常見問題

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.

相關器械（代碼：JEY）

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器材摘要

常見問題

相關臨床試驗

相關器械（代碼：JEY）

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