VariTrax 胸骨環固定系統
K 號：K232986 · 2024-01-30
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器材摘要
VariTrax Sternal CircumFixation System is the device name listed in this FDA 510(k) record. The listed applicant is Circumfix Solutions, Inc.. It received FDA 510(k) clearance on 2024-01-30 under 510(k) number K232986. The device is classified under product code JDQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the VariTrax Sternal CircumFixation System?
VariTrax Sternal CircumFixation System is a medical device that received FDA 510(k) clearance on 2024-01-30. The listed applicant is Circumfix Solutions, Inc.. The 510(k) number is K232986.
When did VariTrax Sternal CircumFixation System receive FDA 510(k) clearance?
VariTrax Sternal CircumFixation System received FDA 510(k) clearance on 2024-01-30, under 510(k) number K232986.
Who is the listed applicant for VariTrax Sternal CircumFixation System?
The FDA 510(k) record lists Circumfix Solutions, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for VariTrax Sternal CircumFixation System?
The FDA product code for VariTrax Sternal CircumFixation System is JDQ.
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相關器械（代碼：JDQ）
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
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