AxoGen 神經帽
K 號：K163446 · 2017-08-08
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器材摘要
AxoGen Nerve Cap is the device name listed in this FDA 510(k) record. The listed applicant is Axogen Corporation. It received FDA 510(k) clearance on 2017-08-08 under 510(k) number K163446. The device is classified under product code JXI. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the AxoGen Nerve Cap?
AxoGen Nerve Cap is a medical device that received FDA 510(k) clearance on 2017-08-08. The listed applicant is Axogen Corporation. The 510(k) number is K163446.
When did AxoGen Nerve Cap receive FDA 510(k) clearance?
AxoGen Nerve Cap received FDA 510(k) clearance on 2017-08-08, under 510(k) number K163446.
Who is the listed applicant for AxoGen Nerve Cap?
The FDA 510(k) record lists Axogen Corporation as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for AxoGen Nerve Cap?
The FDA product code for AxoGen Nerve Cap is JXI.
相關臨床試驗
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其他以 Axogen Corporation 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：JXI）
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
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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