FDA 510(k)

Surgimatix 可吸收固定系統

K 號：K201934 · 2021-10-01

決定日期2021-10-01

產品代碼GDW

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

Surgimatix Absorbable Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Surgimatix, Inc.. It received FDA 510(k) clearance on 2021-10-01 under 510(k) number K201934. The device is classified under product code GDW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Surgimatix Absorbable Fixation System?

Surgimatix Absorbable Fixation System is a medical device that received FDA 510(k) clearance on 2021-10-01. The listed applicant is Surgimatix, Inc.. The 510(k) number is K201934.

When did Surgimatix Absorbable Fixation System receive FDA 510(k) clearance?

Surgimatix Absorbable Fixation System received FDA 510(k) clearance on 2021-10-01, under 510(k) number K201934.

Who is the listed applicant for Surgimatix Absorbable Fixation System?

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

What is the FDA product code for Surgimatix Absorbable Fixation System?

The FDA product code for Surgimatix Absorbable Fixation System is GDW.

相關器械（代碼：GDW）

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官方來源

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器材摘要

常見問題

相關臨床試驗

相關器械（代碼：GDW）

官方來源