精密铸造解決方案全膝系統
K 號：K190355 · 2019-05-16
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器材摘要
Precision Casting Solutions Total Knee System is the device name listed in this FDA 510(k) record. The listed applicant is Precision Casting Solutions, Inc.. It received FDA 510(k) clearance on 2019-05-16 under 510(k) number K190355. 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 Precision Casting Solutions Total Knee System?
Precision Casting Solutions Total Knee System is a medical device that received FDA 510(k) clearance on 2019-05-16. The listed applicant is Precision Casting Solutions, Inc.. The 510(k) number is K190355.
When did Precision Casting Solutions Total Knee System receive FDA 510(k) clearance?
Precision Casting Solutions Total Knee System received FDA 510(k) clearance on 2019-05-16, under 510(k) number K190355.
Who is the listed applicant for Precision Casting Solutions Total Knee System?
The FDA 510(k) record lists Precision Casting Solutions, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Precision Casting Solutions Total Knee System?
The FDA product code for Precision Casting Solutions 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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