FDA 510(k)

TRACKER脊椎成形術系統

K 號：K192335 · 2019-12-04

決定日期2019-12-04

產品代碼NDN

諮詢委員會或

決定相當於

器材摘要

TRACKER 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 2019-12-04 under 510(k) number K192335. 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 Kyphoplasty System?

TRACKER Kyphoplasty System is a medical device that received FDA 510(k) clearance on 2019-12-04. The listed applicant is GS Medical Co., Ltd.. The 510(k) number is K192335.

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

TRACKER Kyphoplasty System received FDA 510(k) clearance on 2019-12-04, under 510(k) number K192335.

Who is the listed applicant for TRACKER 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 Kyphoplasty System?

The FDA product code for TRACKER 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。

K254260VEGA 子宮頸螺釘系統 K243073AnyPlus Navigated Instruments System K241738PYXIS 3D 鈦金屬頸椎金屬支架系統 K240350AnyPlus II 腰椎固定系統 K231808QUASAR 独立式 ACIF 系統 K223868PYXIS 3D 鈦金屬籠架系統

查看所有 14 項裝置 →

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。

K251896XeliteMed 超級固定脊椎骨水泥Xelite Biomed , Ltd.K250637VCFix脊椎系統Amber Implants K243537XeliteMed VertehighFix 高濃度脊椎骨水泥系統Xelite Biomed , Ltd.K241775XeliteMed VertehighFix 高濃度脊椎骨水泥Xelite Biomed , Ltd.K232842氣球充氣系統Ningbo Hicren Biotechnology Co., Ltd.K240084V-STRUT®脊椎植入體Hyprevention

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。