FDA 510(k)

BRIDALVEIL 頸部頸椎胸椎系統

K 號：K171250 · 2017-10-02

決定日期2017-10-02

產品代碼NKG

諮詢委員會或

決定相當於

器材摘要

BRIDALVEIL Occipital Cervical Thoracic System is the device name listed in this FDA 510(k) record. The listed applicant is Astura Medical. It received FDA 510(k) clearance on 2017-10-02 under 510(k) number K171250. The device is classified under product code NKG. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the BRIDALVEIL Occipital Cervical Thoracic System?

BRIDALVEIL Occipital Cervical Thoracic System is a medical device that received FDA 510(k) clearance on 2017-10-02. The listed applicant is Astura Medical. The 510(k) number is K171250.

When did BRIDALVEIL Occipital Cervical Thoracic System receive FDA 510(k) clearance?

BRIDALVEIL Occipital Cervical Thoracic System received FDA 510(k) clearance on 2017-10-02, under 510(k) number K171250.

Who is the listed applicant for BRIDALVEIL Occipital Cervical Thoracic System?

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

What is the FDA product code for BRIDALVEIL Occipital Cervical Thoracic System?

The FDA product code for BRIDALVEIL Occipital Cervical Thoracic System is NKG.

其他以 Astura Medical 為申請人之記錄

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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相關器械（代碼：NKG）

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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