Huvex間盤融合系統
K 號：K223790 · 2023-03-09
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器材摘要
Huvex Interspinous Fusion System is the device name listed in this FDA 510(k) record. The listed applicant is Dio Medical Corp.. It received FDA 510(k) clearance on 2023-03-09 under 510(k) number K223790. The device is classified under product code PEK. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Huvex Interspinous Fusion System?
Huvex Interspinous Fusion System is a medical device that received FDA 510(k) clearance on 2023-03-09. The listed applicant is Dio Medical Corp.. The 510(k) number is K223790.
When did Huvex Interspinous Fusion System receive FDA 510(k) clearance?
Huvex Interspinous Fusion System received FDA 510(k) clearance on 2023-03-09, under 510(k) number K223790.
Who is the listed applicant for Huvex Interspinous Fusion System?
The FDA 510(k) record lists Dio Medical Corp. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Huvex Interspinous Fusion System?
The FDA product code for Huvex Interspinous Fusion System is PEK.
相關臨床試驗
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相關器械（代碼：PEK）
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
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