脊椎康復矯形系統
K 號：K172871 · 2018-05-29
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器材摘要
SpineKure Kyphoplasty System is the device name listed in this FDA 510(k) record. The listed applicant is Hanchang Co., Ltd.. It received FDA 510(k) clearance on 2018-05-29 under 510(k) number K172871. 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 SpineKure Kyphoplasty System?
SpineKure Kyphoplasty System is a medical device that received FDA 510(k) clearance on 2018-05-29. The listed applicant is Hanchang Co., Ltd.. The 510(k) number is K172871.
When did SpineKure Kyphoplasty System receive FDA 510(k) clearance?
SpineKure Kyphoplasty System received FDA 510(k) clearance on 2018-05-29, under 510(k) number K172871.
Who is the listed applicant for SpineKure Kyphoplasty System?
The FDA 510(k) record lists Hanchang Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for SpineKure Kyphoplasty System?
The FDA product code for SpineKure Kyphoplasty System is NDN.
相關臨床試驗
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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。
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。
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