FDA 510(k)

DynaMesh-後置

K 號：K182087 · 2018-10-31

申請人Feg Textiltechnik Forschungs- Und Entwicklungsgesellschaft

決定日期2018-10-31

產品代碼FTL

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

DynaMesh-POSTERIOR is the device name listed in this FDA 510(k) record. The listed applicant is Feg Textiltechnik Forschungs- Und Entwicklungsgesellschaft. It received FDA 510(k) clearance on 2018-10-31 under 510(k) number K182087. The device is classified under product code FTL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the DynaMesh-POSTERIOR?

DynaMesh-POSTERIOR is a medical device that received FDA 510(k) clearance on 2018-10-31. The listed applicant is Feg Textiltechnik Forschungs- Und Entwicklungsgesellschaft. The 510(k) number is K182087.

When did DynaMesh-POSTERIOR receive FDA 510(k) clearance?

DynaMesh-POSTERIOR received FDA 510(k) clearance on 2018-10-31, under 510(k) number K182087.

Who is the listed applicant for DynaMesh-POSTERIOR?

The FDA 510(k) record lists Feg Textiltechnik Forschungs- Und Entwicklungsgesellschaft as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DynaMesh-POSTERIOR?

The FDA product code for DynaMesh-POSTERIOR is FTL.

其他以 Feg Textiltechnik Forschungs- Und Entwicklungsgesellschaft 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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相關器械（代碼：FTL）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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