FDA 510(k)

Gentrix外科矩陣

K 號：K162554 · 2016-10-21

決定日期2016-10-21

產品代碼FTM

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

Gentrix Surgical Matrix is the device name listed in this FDA 510(k) record. The listed applicant is Acell, Inc.. It received FDA 510(k) clearance on 2016-10-21 under 510(k) number K162554. The device is classified under product code FTM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Gentrix Surgical Matrix?

Gentrix Surgical Matrix is a medical device that received FDA 510(k) clearance on 2016-10-21. The listed applicant is Acell, Inc.. The 510(k) number is K162554.

When did Gentrix Surgical Matrix receive FDA 510(k) clearance?

Gentrix Surgical Matrix received FDA 510(k) clearance on 2016-10-21, under 510(k) number K162554.

Who is the listed applicant for Gentrix Surgical Matrix?

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

What is the FDA product code for Gentrix Surgical Matrix?

The FDA product code for Gentrix Surgical Matrix is FTM.

其他以 Acell, Inc. 為申請人之記錄

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相關器械（代碼：FTM）

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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