FDA 510(k)

Durepair Dura再生網絡

K 號：K161370 · 2016-11-02

決定日期2016-11-02

產品代碼GXQ

諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)

決定相當於

器材摘要

Durepair Dura Regeneration Matrix is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Neurosurgery. It received FDA 510(k) clearance on 2016-11-02 under 510(k) number K161370. The device is classified under product code GXQ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Durepair Dura Regeneration Matrix?

Durepair Dura Regeneration Matrix is a medical device that received FDA 510(k) clearance on 2016-11-02. The listed applicant is Medtronic Neurosurgery. The 510(k) number is K161370.

When did Durepair Dura Regeneration Matrix receive FDA 510(k) clearance?

Durepair Dura Regeneration Matrix received FDA 510(k) clearance on 2016-11-02, under 510(k) number K161370.

Who is the listed applicant for Durepair Dura Regeneration Matrix?

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

What is the FDA product code for Durepair Dura Regeneration Matrix?

The FDA product code for Durepair Dura Regeneration Matrix is GXQ.

其他以 Medtronic Neurosurgery 為申請人之記錄

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相關器械（代碼：GXQ）

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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