Rebellion; Phantom Multi-Bite Kerrison Rongeur— 510(k) K221818

Name: FDA 510(k) clearance K221818
Creator: U.S. Food and Drug Administration
Published: 2022-10-07

Substantially Equivalent

Morpheus AG

FDA 510(k) clearance K221818 for Rebellion; Phantom Multi-Bite Kerrison Rongeur, Substantially Equivalent on 2022-10-07. 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: 2022-06-23
Decision date: 2022-10-07
Decision: Substantially Equivalent
Clearance type: Special
Location: Spaichingen, DE

Download summary PDF View on FDA.gov ↗

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K200768 — Rebellion, Phantom Multi-Bite Kerrison Rongeur2021-05-04

Data sourced from openFDA. This site is unofficial and independent of the FDA.