Cleared Traditional

Rebellion, Phantom Multi-Bite Kerrison Rongeur?

K200768 · Morpheus AG · Neurology

May 2021

Decision

405d

Days

Class 2

Risk

About This 510(k) Submission

K200768 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 May 4, 2021, 405 days after receiving the submission on March 25, 2020. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4840.

Submission Details

510(k) Number	K200768 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 25, 2020
Decision Date	May 04, 2021
Days to Decision	405 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF