Rebellion, Phantom Multi-Bite Kerrison Rongeur— 510(k) K200768

Name: FDA 510(k) clearance K200768
Creator: U.S. Food and Drug Administration
Published: 2021-05-04

Substantially Equivalent

Morpheus AG

FDA 510(k) clearance K200768 for Rebellion, Phantom Multi-Bite Kerrison Rongeur, Substantially Equivalent on 2021-05-04. Applicant: Morpheus AG. Device class: 2.

Clearance details

Applicant: Morpheus AG
Product code: Code HAE
Device class: Class 2
Regulation: 21 CFR 882.4840
Advisory panel: Neurology
Date received: 2020-03-25
Decision date: 2021-05-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Spaichingen, DE

Download summary PDF View on FDA.gov ↗

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K210741 — KLS Martin Neuro Rongeurs2022-06-03

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