U2全膝系統，XPE胫骨植入物，PS PLUS
K 號：K210961 · 2021-04-21
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器材摘要
U2 Total Knee System, XPE Tibial Insert, PS PLUS is the device name listed in this FDA 510(k) record. The listed applicant is United Orthopedic Corporation. It received FDA 510(k) clearance on 2021-04-21 under 510(k) number K210961. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the U2 Total Knee System, XPE Tibial Insert, PS PLUS?
U2 Total Knee System, XPE Tibial Insert, PS PLUS is a medical device that received FDA 510(k) clearance on 2021-04-21. The listed applicant is United Orthopedic Corporation. The 510(k) number is K210961.
When did U2 Total Knee System, XPE Tibial Insert, PS PLUS receive FDA 510(k) clearance?
U2 Total Knee System, XPE Tibial Insert, PS PLUS received FDA 510(k) clearance on 2021-04-21, under 510(k) number K210961.
Who is the listed applicant for U2 Total Knee System, XPE Tibial Insert, PS PLUS?
FDA 510(k) 記錄中將 United Orthopedic Corporation 列為申請人。這並不單獨確立該設備製造商的身份。
What is the FDA product code for U2 Total Knee System, XPE Tibial Insert, PS PLUS?
The FDA product code for U2 Total Knee System, XPE Tibial Insert, PS PLUS is JWH.
相關臨床試驗
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。
其他以 United Orthopedic Corporation 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：JWH）
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
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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