德斯特膝全膝系統
K 號：K160771 · 2016-12-19
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器材摘要
Destiknee Total Knee System is the device name listed in this FDA 510(k) record. The listed applicant is Meril Healthcare Private Limited. It received FDA 510(k) clearance on 2016-12-19 under 510(k) number K160771. 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 Destiknee Total Knee System?
Destiknee Total Knee System is a medical device that received FDA 510(k) clearance on 2016-12-19. The listed applicant is Meril Healthcare Private Limited. The 510(k) number is K160771.
When did Destiknee Total Knee System receive FDA 510(k) clearance?
Destiknee Total Knee System received FDA 510(k) clearance on 2016-12-19, under 510(k) number K160771.
Who is the listed applicant for Destiknee Total Knee System?
The FDA 510(k) record lists Meril Healthcare Private Limited as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Destiknee Total Knee System?
The FDA product code for Destiknee Total Knee System is JWH.
相關臨床試驗
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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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