FDA 510(k)

FortiShield（生物合成傷口組織）

K 號：K212579 · 2023-05-02

決定日期2023-05-02

產品代碼KGN

決定相當於

器材摘要

FortiShield (Biosynthetic Wound Matrix) is the device name listed in this FDA 510(k) record. The listed applicant is Organogenesis, Inc.. It received FDA 510(k) clearance on 2023-05-02 under 510(k) number K212579. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

常見問題

What is the FortiShield (Biosynthetic Wound Matrix)?

FortiShield (Biosynthetic Wound Matrix) is a medical device that received FDA 510(k) clearance on 2023-05-02. The listed applicant is Organogenesis, Inc.. The 510(k) number is K212579.

When did FortiShield (Biosynthetic Wound Matrix) receive FDA 510(k) clearance?

FortiShield (Biosynthetic Wound Matrix) received FDA 510(k) clearance on 2023-05-02, under 510(k) number K212579.

Who is the listed applicant for FortiShield (Biosynthetic Wound Matrix)?

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

What is the FDA product code for FortiShield (Biosynthetic Wound Matrix)?

The FDA product code for FortiShield (Biosynthetic Wound Matrix) is KGN.

其他以 Organogenesis, Inc. 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。

K220317PuraPly 微米化傷口組織材（PuraPly MZ）

相關器械（代碼：KGN）

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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