FDA 510(k)

Rebellion; Phantom多咬合Kerrison咬骨钳

K号: K221818 · 2022-10-07

决定日期2022-10-07

产品代码HAE

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决定实质等同

器械摘要

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.

常见问题

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.

列明Morpheus AG为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K230256Rebellion, Phantom多咬合Kerrison咬骨钳 K200768Rebellion, Phantom多咬合Kerrison咬骨钳

官方来源

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