FDA 510(k)

叛亂，幻影多咬合凱遜鋸齒刀

K 號：K230256 · 2023-03-03

決定日期2023-03-03

產品代碼HAE

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

Rebellion, Phantom Multi-Bite Kerrison Rongeur is the device name listed in this FDA 510(k) record. The listed applicant is Morpheus AG. It received FDA 510(k) clearance on 2023-03-03 under 510(k) number K230256. The device is classified under product code HAE. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Rebellion, Phantom Multi-Bite Kerrison Rongeur?

Rebellion, Phantom Multi-Bite Kerrison Rongeur is a medical device that received FDA 510(k) clearance on 2023-03-03. The listed applicant is Morpheus AG. The 510(k) number is K230256.

When did Rebellion, Phantom Multi-Bite Kerrison Rongeur receive FDA 510(k) clearance?

Rebellion, Phantom Multi-Bite Kerrison Rongeur received FDA 510(k) clearance on 2023-03-03, under 510(k) number K230256.

Who is the listed applicant for Rebellion, Phantom Multi-Bite Kerrison Rongeur?

The FDA 510(k) record lists Morpheus AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Rebellion, Phantom Multi-Bite Kerrison Rongeur?

The FDA product code for Rebellion, Phantom Multi-Bite Kerrison Rongeur is HAE.

其他以 Morpheus AG 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。

K221818叛亂；幻影多咬式凱遜咬骨器 K200768叛亂，幻影多咬合凱遜鋸齒刀

相關器械（代碼：HAE）

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。

K260446Tontarra 打擊器與磨削器Tontarra Medizintechnik GmbH K242759Geister K-Rex 適應性咬合器Geister Medizin Technik GmbH K223596SQ.line 賽里遜Aesculap, Inc.K221818叛亂；幻影多咬式凱遜咬骨器Morpheus AG K210741KLS Martin 神經鍵盤KLS-Martin L.P.K200768叛亂，幻影多咬合凱遜鋸齒刀Morpheus AG

官方來源

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