NextAR全膝關節置换平台
K 號：K193559 · 2020-07-10
廣告
器材摘要
NextAR TKA Platform is the device name listed in this FDA 510(k) record. The listed applicant is Medacta Inernational SA. It received FDA 510(k) clearance on 2020-07-10 under 510(k) number K193559. The device is classified under product code SBF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the NextAR TKA Platform?
NextAR TKA Platform is a medical device that received FDA 510(k) clearance on 2020-07-10. The listed applicant is Medacta Inernational SA. The 510(k) number is K193559.
When did NextAR TKA Platform receive FDA 510(k) clearance?
NextAR TKA Platform received FDA 510(k) clearance on 2020-07-10, under 510(k) number K193559.
Who is the listed applicant for NextAR TKA Platform?
The FDA 510(k) record lists Medacta Inernational SA as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for NextAR TKA Platform?
The FDA product code for NextAR TKA Platform is SBF.
相關臨床試驗
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其他以 Medacta Inernational SA 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。
相關器械（代碼：SBF）
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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