ALTA 前頸椎間置器
K 號：K173324 · 2018-02-27
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器材摘要
ALTA Anterior Cervical Interbody Spacer is the device name listed in this FDA 510(k) record. The listed applicant is Astura Medical. It received FDA 510(k) clearance on 2018-02-27 under 510(k) number K173324. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the ALTA Anterior Cervical Interbody Spacer?
ALTA Anterior Cervical Interbody Spacer is a medical device that received FDA 510(k) clearance on 2018-02-27. The listed applicant is Astura Medical. The 510(k) number is K173324.
When did ALTA Anterior Cervical Interbody Spacer receive FDA 510(k) clearance?
ALTA Anterior Cervical Interbody Spacer received FDA 510(k) clearance on 2018-02-27, under 510(k) number K173324.
Who is the listed applicant for ALTA Anterior Cervical Interbody Spacer?
The FDA 510(k) record lists Astura Medical as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ALTA Anterior Cervical Interbody Spacer?
The FDA product code for ALTA Anterior Cervical Interbody Spacer is ODP.
相關臨床試驗
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其他以 Astura Medical 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：ODP）
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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