FDA 510(k)

黑钻椎板螺釘系統

K 號：K192121 · 2019-10-29

決定日期2019-10-29

產品代碼NKB

諮詢委員會或

決定相當於

器材摘要

Black Diamond Pedicle Screw System is the device name listed in this FDA 510(k) record. The listed applicant is Osseus Fusion Systems. It received FDA 510(k) clearance on 2019-10-29 under 510(k) number K192121. 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 Black Diamond Pedicle Screw System?

Black Diamond Pedicle Screw System is a medical device that received FDA 510(k) clearance on 2019-10-29. The listed applicant is Osseus Fusion Systems. The 510(k) number is K192121.

When did Black Diamond Pedicle Screw System receive FDA 510(k) clearance?

Black Diamond Pedicle Screw System received FDA 510(k) clearance on 2019-10-29, under 510(k) number K192121.

Who is the listed applicant for Black Diamond Pedicle Screw System?

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

What is the FDA product code for Black Diamond Pedicle Screw System?

The FDA product code for Black Diamond Pedicle Screw System is NKB.

其他以 Osseus Fusion Systems 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：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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