Aurora® 前腰椎板系統
K 號：K201079 · 2020-08-05
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器材摘要
Aurora® Anterior Lumbar Plate Sytstem is the device name listed in this FDA 510(k) record. The listed applicant is Prism Surgical Design Pty , Ltd.. It received FDA 510(k) clearance on 2020-08-05 under 510(k) number K201079. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Aurora® Anterior Lumbar Plate Sytstem?
Aurora® Anterior Lumbar Plate Sytstem is a medical device that received FDA 510(k) clearance on 2020-08-05. The listed applicant is Prism Surgical Design Pty , Ltd.. The 510(k) number is K201079.
When did Aurora® Anterior Lumbar Plate Sytstem receive FDA 510(k) clearance?
Aurora® Anterior Lumbar Plate Sytstem received FDA 510(k) clearance on 2020-08-05, under 510(k) number K201079.
Who is the listed applicant for Aurora® Anterior Lumbar Plate Sytstem?
The FDA 510(k) record lists Prism Surgical Design Pty , Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Aurora® Anterior Lumbar Plate Sytstem?
The FDA product code for Aurora® Anterior Lumbar Plate Sytstem is KWQ.
相關臨床試驗
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：KWQ）
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
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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