FDA 510(k)

TRACKER Plus 骨水泥填充系統

K 號：K211797 · 2021-10-28

決定日期2021-10-28

產品代碼NDN

諮詢委員會或

決定相當於

器材摘要

TRACKER Plus Kyphoplasty System is the device name listed in this FDA 510(k) record. The listed applicant is GS Medical Co., Ltd.. It received FDA 510(k) clearance on 2021-10-28 under 510(k) number K211797. The device is classified under product code NDN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the TRACKER Plus Kyphoplasty System?

TRACKER Plus Kyphoplasty System is a medical device that received FDA 510(k) clearance on 2021-10-28. The listed applicant is GS Medical Co., Ltd.. The 510(k) number is K211797.

When did TRACKER Plus Kyphoplasty System receive FDA 510(k) clearance?

TRACKER Plus Kyphoplasty System received FDA 510(k) clearance on 2021-10-28, under 510(k) number K211797.

Who is the listed applicant for TRACKER Plus Kyphoplasty System?

FDA 510(k)記錄將GS Medical Co., Ltd.列為申請人。這本身並不足以確立設備製造商。

What is the FDA product code for TRACKER Plus Kyphoplasty System?

The FDA product code for TRACKER Plus Kyphoplasty System is NDN.

其他以 GS Medical Co., Ltd. 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：NDN）

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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