客製化骨質服務
K 號：K193547 · 2020-01-17
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器材摘要
CustomizedBone Service is the device name listed in this FDA 510(k) record. The listed applicant is Fin-Ceramica Faenza S.P.A.. It received FDA 510(k) clearance on 2020-01-17 under 510(k) number K193547. The device is classified under product code GXN. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the CustomizedBone Service?
CustomizedBone Service is a medical device that received FDA 510(k) clearance on 2020-01-17. The listed applicant is Fin-Ceramica Faenza S.P.A.. The 510(k) number is K193547.
When did CustomizedBone Service receive FDA 510(k) clearance?
CustomizedBone Service received FDA 510(k) clearance on 2020-01-17, under 510(k) number K193547.
Who is the listed applicant for CustomizedBone Service?
The FDA 510(k) record lists Fin-Ceramica Faenza S.P.A. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for CustomizedBone Service?
The FDA product code for CustomizedBone Service is GXN.
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。
其他以 Fin-Ceramica Faenza S.P.A. 為申請人之記錄
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：GXN）
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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