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FDA 510(k)

Rebellion, Phantom Multi-Bite Kerrison Rongeur

K-Number: K230256 · 2023-03-03

ApplicantMorpheus AG
Decision Date2023-03-03
Product CodeHAE
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Morpheus AG. The 510(k) number is K230256.

When was Rebellion, Phantom Multi-Bite Kerrison Rongeur approved by the FDA?

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

What company makes Rebellion, Phantom Multi-Bite Kerrison Rongeur?

Rebellion, Phantom Multi-Bite Kerrison Rongeur is manufactured by Morpheus AG.

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.

Other Devices by Morpheus AG

Related Devices (Code: HAE)

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.