AFX股骨植入體配植入器
K 號：K192428 · 2019-10-05
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器材摘要
AFX Femoral Implant with Inserter is the device name listed in this FDA 510(k) record. The listed applicant is Cayenne Medical. It received FDA 510(k) clearance on 2019-10-05 under 510(k) number K192428. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the AFX Femoral Implant with Inserter?
AFX Femoral Implant with Inserter is a medical device that received FDA 510(k) clearance on 2019-10-05. The listed applicant is Cayenne Medical. The 510(k) number is K192428.
When did AFX Femoral Implant with Inserter receive FDA 510(k) clearance?
AFX Femoral Implant with Inserter received FDA 510(k) clearance on 2019-10-05, under 510(k) number K192428.
Who is the listed applicant for AFX Femoral Implant with Inserter?
The FDA 510(k) record lists Cayenne Medical as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for AFX Femoral Implant with Inserter?
The FDA product code for AFX Femoral Implant with Inserter is MBI.
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：MBI）
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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