FDA 510(k)

ExpressBraid 繁殖組織操作器

K 號：K163651 · 2017-02-17

決定日期2017-02-17

產品代碼GAT

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

ExpressBraid Graft Manipulation is the device name listed in this FDA 510(k) record. The listed applicant is Biomet Manufacturing Corp. It received FDA 510(k) clearance on 2017-02-17 under 510(k) number K163651. The device is classified under product code GAT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ExpressBraid Graft Manipulation?

ExpressBraid Graft Manipulation is a medical device that received FDA 510(k) clearance on 2017-02-17. The listed applicant is Biomet Manufacturing Corp. The 510(k) number is K163651.

When did ExpressBraid Graft Manipulation receive FDA 510(k) clearance?

ExpressBraid Graft Manipulation received FDA 510(k) clearance on 2017-02-17, under 510(k) number K163651.

Who is the listed applicant for ExpressBraid Graft Manipulation?

The FDA 510(k) record lists Biomet Manufacturing Corp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ExpressBraid Graft Manipulation?

The FDA product code for ExpressBraid Graft Manipulation is GAT.

其他以 Biomet Manufacturing Corp 為申請人之記錄

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相關器械（代碼：GAT）

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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