Cleared Special

Rebellion, Phantom Multi-Bite Kerrison Rongeur

K230256 · Morpheus AG · Neurology

Mar 2023

Decision

31d

Days

Class 2

Risk

About This 510(k) Submission

K230256 is an FDA 510(k) clearance for the Rebellion, Phantom Multi-Bite Kerrison Rongeur, a Rongeur, Manual (Class II — Special Controls, product code HAE), submitted by Morpheus AG (Spaichingen, DE). The FDA issued a Cleared decision on March 3, 2023, 31 days after receiving the submission on January 31, 2023. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4840.

Submission Details

510(k) Number	K230256 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 31, 2023
Decision Date	March 03, 2023
Days to Decision	31 days
Submission Type	Special
Review Panel	Neurology (NE)
Summary	Summary PDF