FDA 510(k)

固定式Asfora BULLET CAGE® (FABC)

K 號：K181591 · 2018-09-26

決定日期2018-09-26

產品代碼MAX

諮詢委員會或

決定相當於

器材摘要

Fixated Asfora BULLET CAGE® (FABC) is the device name listed in this FDA 510(k) record. The listed applicant is Medical Designs, LLC. It received FDA 510(k) clearance on 2018-09-26 under 510(k) number K181591. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Fixated Asfora BULLET CAGE® (FABC)?

Fixated Asfora BULLET CAGE® (FABC) is a medical device that received FDA 510(k) clearance on 2018-09-26. The listed applicant is Medical Designs, LLC. The 510(k) number is K181591.

When did Fixated Asfora BULLET CAGE® (FABC) receive FDA 510(k) clearance?

Fixated Asfora BULLET CAGE® (FABC) received FDA 510(k) clearance on 2018-09-26, under 510(k) number K181591.

Who is the listed applicant for Fixated Asfora BULLET CAGE® (FABC)?

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

What is the FDA product code for Fixated Asfora BULLET CAGE® (FABC)?

The FDA product code for Fixated Asfora BULLET CAGE® (FABC) is MAX.

其他以 Medical Designs, LLC 為申請人之記錄

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相關器械（代碼：MAX）

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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