Cleared Traditional

K172603 - Cerafix Dura Substitute
(FDA 510(k) Clearance)

K172603 · Acera Surgical, Inc. · Neurology

Nov 2017

Decision

89d

Days

Class 2

Risk

K172603 is an FDA 510(k) clearance for the Cerafix Dura Substitute. This device is classified as a Dura Substitute (Class II — Special Controls, product code GXQ).

Submitted by Acera Surgical, Inc. (St. Louis, US). The FDA issued a Cleared decision on November 27, 2017, 89 days after receiving the submission on August 30, 2017.

This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5910.

Submission Details

510(k) Number	K172603 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 30, 2017
Decision Date	November 27, 2017
Days to Decision	89 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF