Cleared Traditional

K153613 - Cerafix Dura Substitute

K153613 is an FDA 510(k) clearance for Cerafix Dura Substitute, manufactured by Acera Surgical, Inc.. The device is a Class 2 Neurology device with product code GXQ cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K153613 · Acera Surgical, Inc. · Neurology device
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Mar 2016
Decision
90d
Days
Class 2
Risk

K153613 is an FDA 510(k) clearance for the Cerafix Dura Substitute. Classified as Dura Substitute (product code GXQ), Class II - Special Controls.

Submitted by Acera Surgical, Inc. (St. Louis, US). The FDA issued a Cleared decision on March 16, 2016 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5910 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Acera Surgical, Inc. devices

FDA 510(k) Submission Details - K153613

510(k) Number K153613 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 2015
Decision Date March 16, 2016
Days to Decision 90 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 148d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GXQ Device Classification - Class 2, Special Controls

Product Code GXQ Dura Substitute
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5910
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - GXQ Dura Substitute

All 33
Devices cleared under the same product code (GXQ) and FDA review panel - the closest regulatory comparables to K153613.
XenoSure Dura Biologic Patch
K183513 · LeMaitre Vascular, Inc. · Jun 2019
DuraGen Secure Dural Regeneration Matrix
K163456 · Integra LifeSciences Corporation · Jan 2017
Durepair Dura Regeneration Matrix
K161370 · Medtronic Neurosurgery · Nov 2016
Collagen Dural Regeneration Matrix
K150825 · Collagen Matrix, Inc. · Nov 2015
DURAFORM Dural Graft Implant
K152481 · Codman & Shurtleff, Inc. · Oct 2015
COLLAGEN DURA MEMBRANE
K141608 · Collagen Matrix, Inc. · Jan 2015