EVOLUTION NitrX 中立軸膝關節
K 號：K182251 · 2019-05-16
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器材摘要
EVOLUTION NitrX Medial-Pivot Knee is the device name listed in this FDA 510(k) record. The listed applicant is Mircoport Orthopedics, Inc.. It received FDA 510(k) clearance on 2019-05-16 under 510(k) number K182251. 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 EVOLUTION NitrX Medial-Pivot Knee?
EVOLUTION NitrX Medial-Pivot Knee is a medical device that received FDA 510(k) clearance on 2019-05-16. The listed applicant is Mircoport Orthopedics, Inc.. The 510(k) number is K182251.
When did EVOLUTION NitrX Medial-Pivot Knee receive FDA 510(k) clearance?
EVOLUTION NitrX Medial-Pivot Knee received FDA 510(k) clearance on 2019-05-16, under 510(k) number K182251.
Who is the listed applicant for EVOLUTION NitrX Medial-Pivot Knee?
The FDA 510(k) record lists Mircoport Orthopedics, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for EVOLUTION NitrX Medial-Pivot Knee?
The FDA product code for EVOLUTION NitrX Medial-Pivot 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。
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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