FDA 510(k)

Diplomat®脊椎系統

K 號：K151704 · 2016-04-13

決定日期2016-04-13

產品代碼NKB

諮詢委員會或

決定相當於

器材摘要

Diplomat® Spinal System is the device name listed in this FDA 510(k) record. The listed applicant is Signus Medizintechnik GmbH. It received FDA 510(k) clearance on 2016-04-13 under 510(k) number K151704. 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 Diplomat® Spinal System?

Diplomat® Spinal System is a medical device that received FDA 510(k) clearance on 2016-04-13. The listed applicant is Signus Medizintechnik GmbH. The 510(k) number is K151704.

When did Diplomat® Spinal System receive FDA 510(k) clearance?

Diplomat® Spinal System received FDA 510(k) clearance on 2016-04-13, under 510(k) number K151704.

Who is the listed applicant for Diplomat® Spinal System?

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

What is the FDA product code for Diplomat® Spinal System?

The FDA product code for Diplomat® Spinal System is NKB.

其他以 Signus Medizintechnik GmbH 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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官方來源

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