FDA 510(k)

Avitus® 精準自體移植物遞送系統

K 號：K230492 · 2023-06-26

決定日期2023-06-26

產品代碼FMF

諮詢委員會醫療設備規範文本翻譯如下： HO 注意：原文中未提供具體的醫療設備規範文本，因此上述翻譯僅為示例。請提供完整的規範文本以便進行準確翻譯。

決定相當於

器材摘要

Avitus® Precision Autograft Delivery System is the device name listed in this FDA 510(k) record. The listed applicant is Avitus Orthopaedics, Inc.. It received FDA 510(k) clearance on 2023-06-26 under 510(k) number K230492. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Avitus® Precision Autograft Delivery System?

Avitus® Precision Autograft Delivery System is a medical device that received FDA 510(k) clearance on 2023-06-26. The listed applicant is Avitus Orthopaedics, Inc.. The 510(k) number is K230492.

When did Avitus® Precision Autograft Delivery System receive FDA 510(k) clearance?

Avitus® Precision Autograft Delivery System received FDA 510(k) clearance on 2023-06-26, under 510(k) number K230492.

Who is the listed applicant for Avitus® Precision Autograft Delivery System?

The FDA 510(k) record lists Avitus Orthopaedics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Avitus® Precision Autograft Delivery System?

The FDA product code for Avitus® Precision Autograft Delivery System is FMF.

其他以 Avitus Orthopaedics, Inc. 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。

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相關器械（代碼：FMF）

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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