Bonalive 頭顎外科
K 號：K253883 · 2026-05-14
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器材摘要
Bonalive Maxillofacial is the device name listed in this FDA 510(k) record. The listed applicant is Bonalive , Ltd.. It received FDA 510(k) clearance on 2026-05-14 under 510(k) number K253883. The device is classified under product code LYC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Bonalive Maxillofacial?
Bonalive Maxillofacial is a medical device that received FDA 510(k) clearance on 2026-05-14. The listed applicant is Bonalive , Ltd.. The 510(k) number is K253883.
When did Bonalive Maxillofacial receive FDA 510(k) clearance?
Bonalive Maxillofacial received FDA 510(k) clearance on 2026-05-14, under 510(k) number K253883.
Who is the listed applicant for Bonalive Maxillofacial?
The FDA 510(k) record lists Bonalive , Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Bonalive Maxillofacial?
The FDA product code for Bonalive Maxillofacial is LYC.
相關臨床試驗
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相關器械（代碼：LYC）
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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