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FDA 510(k)

Rebellion; Phantom Multi-Bite Kerrison Rongeur

K-Number: K221818 · 2022-10-07

ApplicantMorpheus AG
Decision Date2022-10-07
Product CodeHAE
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

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.

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. 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.

Other records listing Morpheus AG as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K230256Rebellion, Phantom Multi-Bite Kerrison RongeurK200768Rebellion, Phantom Multi-Bite Kerrison Rongeur

Related Devices (Code: HAE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K242759Geister K-Rex rongeursGeister Medizin Technik GmbHK223596SQ.line KERRISONAesculap, Inc.K230256Rebellion, Phantom Multi-Bite Kerrison RongeurMorpheus AGK210741KLS Martin Neuro RongeursKLS-Martin L.P.K200768Rebellion, Phantom Multi-Bite Kerrison RongeurMorpheus AGK200387Ace Medical Surgical InstrumentsAce Medical

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.

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