Cleared Traditional

Cerafix Dura Substitute

K161278 · Acera Surgical, Inc. · Neurology
Aug 2016
Decision
94d
Days
Class 2
Risk

About This 510(k) Submission

K161278 is an FDA 510(k) clearance for the Cerafix Dura Substitute, 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 August 8, 2016, 94 days after receiving the submission on May 6, 2016. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5910.

Submission Details

510(k) Number K161278 FDA.gov
FDA Decision Cleared SESE
Date Received May 06, 2016
Decision Date August 08, 2016
Days to Decision 94 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code GXQ — Dura Substitute
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.5910