FDA 510(k)

Rebellion; Phantom Multi-Bite Kerrison Rongeur

K-Number: K221818 · 2022-10-07

Decision Date2022-10-07

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 2022-10-07 under approval number K221818. 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 2022-10-07. It is manufactured by Morpheus AG. The 510(k) number is K221818.

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

Rebellion; Phantom Multi-Bite Kerrison Rongeur received FDA 510(k) clearance on 2022-10-07, under approval number K221818.

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

K200768Rebellion, Phantom Multi-Bite Kerrison Rongeur K230256Rebellion, Phantom Multi-Bite Kerrison Rongeur

Related Devices (Code: HAE)

K161744Symmetry Sharp Kerrison RongeurSymmetry Surgical, Inc. K153243Fehling-PunchesFehling Instruments GmbH & Co. KG K152734Kerrison RongeursVitalitec Medizintechnik GmbH K150468Laminectomy Rongeurs, Kerrison Rongeurs, IVD RongeursK2 Medical GmbH & Co. KG K180949SteribiteRjr Surgical, Inc. K200383Wiggins Medical Surgical InstrumentsWiggins Medical

Official Source

View on FDA Database →

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