JOURNEY II UK™ 及 ENGAGE™ 非骨水泥部分膝關節系統
K 號：K222653 · 2022-10-28
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器材摘要
JOURNEY II UK™ and ENGAGE™ Cementless Partial Knee System is the device name listed in this FDA 510(k) record. The listed applicant is Smith+Nephew, Inc.. It received FDA 510(k) clearance on 2022-10-28 under 510(k) number K222653. The device is classified under product code NJD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the JOURNEY II UK™ and ENGAGE™ Cementless Partial Knee System?
JOURNEY II UK™ and ENGAGE™ Cementless Partial Knee System is a medical device that received FDA 510(k) clearance on 2022-10-28. The listed applicant is Smith+Nephew, Inc.. The 510(k) number is K222653.
When did JOURNEY II UK™ and ENGAGE™ Cementless Partial Knee System receive FDA 510(k) clearance?
JOURNEY II UK™ and ENGAGE™ Cementless Partial Knee System received FDA 510(k) clearance on 2022-10-28, under 510(k) number K222653.
Who is the listed applicant for JOURNEY II UK™ and ENGAGE™ Cementless Partial Knee System?
The FDA 510(k) record lists Smith+Nephew, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for JOURNEY II UK™ and ENGAGE™ Cementless Partial Knee System?
The FDA product code for JOURNEY II UK™ and ENGAGE™ Cementless Partial Knee System is NJD.
相關臨床試驗
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相關器械（代碼：NJD）
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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