FDA 510(k)

叛亂；幻影多咬式凱遜咬骨器

K 號：K221818 · 2022-10-07

決定日期2022-10-07

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 2022-10-07 under 510(k) number K221818. 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 2022-10-07. The listed applicant is Morpheus AG. The 510(k) number is K221818.

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 2022-10-07, under 510(k) number K221818.

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。

K230256叛亂，幻影多咬合凱遜鋸齒刀 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.K230256叛亂，幻影多咬合凱遜鋸齒刀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

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。