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FDA 510(k)

Australis 前腰椎籠系統

K 號：K202820 · 2020-12-22

申請人Prism Surgical Designs Pty, Ltd.
決定日期2020-12-22
產品代碼MAX
諮詢委員會或
決定相當於

器材摘要

Australis Anterior Lumbar Cage System is the device name listed in this FDA 510(k) record. The listed applicant is Prism Surgical Designs Pty, Ltd.. It received FDA 510(k) clearance on 2020-12-22 under 510(k) number K202820. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Australis Anterior Lumbar Cage System?

Australis Anterior Lumbar Cage System is a medical device that received FDA 510(k) clearance on 2020-12-22. The listed applicant is Prism Surgical Designs Pty, Ltd.. The 510(k) number is K202820.

When did Australis Anterior Lumbar Cage System receive FDA 510(k) clearance?

Australis Anterior Lumbar Cage System received FDA 510(k) clearance on 2020-12-22, under 510(k) number K202820.

Who is the listed applicant for Australis Anterior Lumbar Cage System?

The FDA 510(k) record lists Prism Surgical Designs Pty, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Australis Anterior Lumbar Cage System?

The FDA product code for Australis Anterior Lumbar Cage System is MAX.

相關臨床試驗

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相關器械（代碼：MAX）

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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