FDA 510(k)

EL CAPITAN 前腰椎間融合系統

K 號：K214047 · 2022-03-30

決定日期2022-03-30

產品代碼OVD

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器材摘要

EL CAPITAN Anterior Lumbar Interbody Fusion System is the device name listed in this FDA 510(k) record. The listed applicant is Astura Medical. It received FDA 510(k) clearance on 2022-03-30 under 510(k) number K214047. The device is classified under product code OVD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the EL CAPITAN Anterior Lumbar Interbody Fusion System?

EL CAPITAN Anterior Lumbar Interbody Fusion System is a medical device that received FDA 510(k) clearance on 2022-03-30. The listed applicant is Astura Medical. The 510(k) number is K214047.

When did EL CAPITAN Anterior Lumbar Interbody Fusion System receive FDA 510(k) clearance?

EL CAPITAN Anterior Lumbar Interbody Fusion System received FDA 510(k) clearance on 2022-03-30, under 510(k) number K214047.

Who is the listed applicant for EL CAPITAN Anterior Lumbar Interbody Fusion System?

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 EL CAPITAN Anterior Lumbar Interbody Fusion System?

The FDA product code for EL CAPITAN Anterior Lumbar Interbody Fusion System is OVD.

其他以 Astura Medical 為申請人之記錄

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相關器械（代碼：OVD）

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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