Class Class II

Rebellion, Phantom Multi-Bite Kerrison Rongeur (K230256)

K230256 2023-03-03 Special
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Description

Rebellion, Phantom Multi-Bite Kerrison Rongeur by Morpheus AG, an FDA 510(k) cleared neurology device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK230256
Clearance Date2023-03-03
Clearance TypeSpecial
Product CodeHAE
Regulation Number882.4840

Categories

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Predicate lineage for K230256

A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Rebellion, Phantom Multi-Bite Kerrison Rongeur (K230256) cites 2 predicate devices and is itself cited by 0 later devices.

Predicate devices cited by this clearance

Devices this clearance was compared against
K numberDeviceApplicantYear
K221818Rebellion; Phantom Multi-Bite Kerrison RongeurMorpheus AG2022
K200768Rebellion, Phantom Multi-Bite Kerrison RongeurMorpheus AG2021

Trace the full predicate network for K230256

A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.

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