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FDA 510(k)

Rebellion, Phantom Multi-Bite Kerrison Rongeur

K-Number: K200768 · 2021-05-04

ApplicantMorpheus AG
Decision Date2021-05-04
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 2021-05-04 under 510(k) number K200768. 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 2021-05-04. The listed applicant is Morpheus AG. The 510(k) number is K200768.

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 2021-05-04, under 510(k) number K200768.

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 RongeurK221818Rebellion; 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 AGK221818Rebellion; Phantom Multi-Bite Kerrison RongeurMorpheus AGK210741KLS Martin Neuro RongeursKLS-Martin L.P.K200387Ace 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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