FDA 510(k)

重建神經導引管

K 號：K230794 · 2024-01-29

決定日期2024-01-29

產品代碼JXI

諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)

決定相當於

器材摘要

Rebuilder Nerve Guidance Conduit is the device name listed in this FDA 510(k) record. The listed applicant is Celestray Biotech Company, LLC.,. It received FDA 510(k) clearance on 2024-01-29 under 510(k) number K230794. 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 Rebuilder Nerve Guidance Conduit?

Rebuilder Nerve Guidance Conduit is a medical device that received FDA 510(k) clearance on 2024-01-29. The listed applicant is Celestray Biotech Company, LLC.,. The 510(k) number is K230794.

When did Rebuilder Nerve Guidance Conduit receive FDA 510(k) clearance?

Rebuilder Nerve Guidance Conduit received FDA 510(k) clearance on 2024-01-29, under 510(k) number K230794.

Who is the listed applicant for Rebuilder Nerve Guidance Conduit?

The FDA 510(k) record lists Celestray Biotech Company, LLC., as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Rebuilder Nerve Guidance Conduit?

The FDA product code for Rebuilder Nerve Guidance Conduit is JXI.

其他以 Celestray Biotech Company, LLC., 為申請人之記錄

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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

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