再生生物導引式植入體
K 號：K222501 · 2023-05-11
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器材摘要
Regeneten Bioinductive Implant is the device name listed in this FDA 510(k) record. The listed applicant is Smith and Nephew, Inc.. It received FDA 510(k) clearance on 2023-05-11 under 510(k) number K222501. The device is classified under product code OWY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Regeneten Bioinductive Implant?
Regeneten Bioinductive Implant is a medical device that received FDA 510(k) clearance on 2023-05-11. The listed applicant is Smith and Nephew, Inc.. The 510(k) number is K222501.
When did Regeneten Bioinductive Implant receive FDA 510(k) clearance?
Regeneten Bioinductive Implant received FDA 510(k) clearance on 2023-05-11, under 510(k) number K222501.
Who is the listed applicant for Regeneten Bioinductive Implant?
The FDA 510(k) record lists Smith and Nephew, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Regeneten Bioinductive Implant?
The FDA product code for Regeneten Bioinductive Implant is OWY.
相關臨床試驗
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其他以 Smith and Nephew, Inc. 為申請人之記錄
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相關器械（代碼：OWY）
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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