Cleared Traditional

ArtiFascia

K223445 · Nurami Medical , Ltd. · Neurology

Aug 2023

Decision

269d

Days

Class 2

Risk

About This 510(k) Submission

K223445 is an FDA 510(k) clearance for the ArtiFascia, a Dura Substitute (Class II — Special Controls, product code GXQ), submitted by Nurami Medical , Ltd. (Haifa, IL). The FDA issued a Cleared decision on August 10, 2023, 269 days after receiving the submission on November 14, 2022. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5910.

Submission Details

510(k) Number	K223445 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 14, 2022
Decision Date	August 10, 2023
Days to Decision	269 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF