FDA 510(k)

動力™ 頸椎後固定系統

K 號：K191932 · 2019-10-02

決定日期2019-10-02

產品代碼NKB

諮詢委員會或

決定相當於

器材摘要

Momentum™ Posterior Spinal Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Ulrich Medical USA. It received FDA 510(k) clearance on 2019-10-02 under 510(k) number K191932. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Momentum™ Posterior Spinal Fixation System?

Momentum™ Posterior Spinal Fixation System is a medical device that received FDA 510(k) clearance on 2019-10-02. The listed applicant is Ulrich Medical USA. The 510(k) number is K191932.

When did Momentum™ Posterior Spinal Fixation System receive FDA 510(k) clearance?

Momentum™ Posterior Spinal Fixation System received FDA 510(k) clearance on 2019-10-02, under 510(k) number K191932.

Who is the listed applicant for Momentum™ Posterior Spinal Fixation System?

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

What is the FDA product code for Momentum™ Posterior Spinal Fixation System?

The FDA product code for Momentum™ Posterior Spinal Fixation System is NKB.

其他以 Ulrich Medical USA 為申請人之記錄

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相關器械（代碼：NKB）

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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