Cleared Special

K221818 - Rebellion (FDA 510(k) Clearance)

Also includes:

Phantom Multi-Bite Kerrison Rongeur

K221818 · Morpheus AG · Neurology device

Oct 2022

Decision

106d

Days

Class 2

Risk

K221818 is an FDA 510(k) clearance for the Rebellion. This device is classified as a Rongeur, Manual (Class II - Special Controls, product code HAE).

Submitted by Morpheus AG (Spaichingen, DE). The FDA issued a Cleared decision on October 7, 2022, 106 days after receiving the submission on June 23, 2022.

This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4840.

Submission Details

510(k) Number	K221818 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 23, 2022
Decision Date	October 07, 2022
Days to Decision	106 days
Submission Type	Special
Review Panel	Neurology (NE)
Summary	Summary PDF