EMPOWR 修復膝關節
K 號：K213793 · 2022-04-01
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器材摘要
EMPOWR Revision Knee is the device name listed in this FDA 510(k) record. The listed applicant is Encore Medical L.P.. It received FDA 510(k) clearance on 2022-04-01 under 510(k) number K213793. 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 EMPOWR Revision Knee?
EMPOWR Revision Knee is a medical device that received FDA 510(k) clearance on 2022-04-01. The listed applicant is Encore Medical L.P.. The 510(k) number is K213793.
When did EMPOWR Revision Knee receive FDA 510(k) clearance?
EMPOWR Revision Knee received FDA 510(k) clearance on 2022-04-01, under 510(k) number K213793.
Who is the listed applicant for EMPOWR Revision Knee?
The FDA 510(k) record lists Encore Medical L.P. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for EMPOWR Revision Knee?
The FDA product code for EMPOWR Revision Knee 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 Encore Medical L.P. 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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