骨信植入系統
K 號：K182313 · 2019-03-11
廣告
器材摘要
BoneTrust Implant System is the device name listed in this FDA 510(k) record. The listed applicant is Medical Instinct Deutschland GmbH. It received FDA 510(k) clearance on 2019-03-11 under 510(k) number K182313. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the BoneTrust Implant System?
BoneTrust Implant System is a medical device that received FDA 510(k) clearance on 2019-03-11. The listed applicant is Medical Instinct Deutschland GmbH. The 510(k) number is K182313.
When did BoneTrust Implant System receive FDA 510(k) clearance?
BoneTrust Implant System received FDA 510(k) clearance on 2019-03-11, under 510(k) number K182313.
Who is the listed applicant for BoneTrust Implant System?
The FDA 510(k) record lists Medical Instinct Deutschland GmbH as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for BoneTrust Implant System?
The FDA product code for BoneTrust Implant System is DZE.
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 Medical Instinct Deutschland GmbH 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：DZE）
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。
廣告