FDA 510(k)

Cerafix Dura 代用品

K 號：K161278 · 2016-08-08

決定日期2016-08-08

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

Cerafix Dura Substitute is the device name listed in this FDA 510(k) record. The listed applicant is Acera Surgical, Inc.. It received FDA 510(k) clearance on 2016-08-08 under 510(k) number K161278. 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 Cerafix Dura Substitute?

Cerafix Dura Substitute is a medical device that received FDA 510(k) clearance on 2016-08-08. The listed applicant is Acera Surgical, Inc.. The 510(k) number is K161278.

When did Cerafix Dura Substitute receive FDA 510(k) clearance?

Cerafix Dura Substitute received FDA 510(k) clearance on 2016-08-08, under 510(k) number K161278.

Who is the listed applicant for Cerafix Dura Substitute?

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

What is the FDA product code for Cerafix Dura Substitute?

The FDA product code for Cerafix Dura Substitute is GXQ.

其他以 Acera Surgical, Inc. 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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