FDA 510(k)

福蒂斯與漢娜前頸椎板系統

K 號：K173099 · 2017-11-30

決定日期2017-11-30

產品代碼KWQ

諮詢委員會或

決定相當於

器材摘要

Fortis and Hana Anterior Cervical Plate System is the device name listed in this FDA 510(k) record. The listed applicant is Huvexel Co. , Ltd.. It received FDA 510(k) clearance on 2017-11-30 under 510(k) number K173099. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Fortis and Hana Anterior Cervical Plate System?

Fortis and Hana Anterior Cervical Plate System is a medical device that received FDA 510(k) clearance on 2017-11-30. The listed applicant is Huvexel Co. , Ltd.. The 510(k) number is K173099.

When did Fortis and Hana Anterior Cervical Plate System receive FDA 510(k) clearance?

Fortis and Hana Anterior Cervical Plate System received FDA 510(k) clearance on 2017-11-30, under 510(k) number K173099.

Who is the listed applicant for Fortis and Hana Anterior Cervical Plate System?

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

What is the FDA product code for Fortis and Hana Anterior Cervical Plate System?

The FDA product code for Fortis and Hana Anterior Cervical Plate System is KWQ.

其他以 Huvexel Co. , Ltd. 為申請人之記錄

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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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