Cleared Traditional

K172603 - Cerafix Dura Substitute

K172603 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 89-day FDA review.

K172603 · Acera Surgical, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2017
Decision
89d
Days
Class 2
Risk

K172603 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 November 27, 2017 after a review of 89 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Acera Surgical, Inc. devices

FDA 510(k) Submission Details - K172603

510(k) Number K172603 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 149d · This submission: 89d
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 Consultant

Secure BioMed Evaluations
Linda Braddon

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - GXQ Dura Substitute

All 42
Devices cleared under the same product code (GXQ) and FDA review panel - the closest regulatory comparables to K172603.
ArtiFascia
K223445 · Nurami Medical , Ltd. · Aug 2023
SyntheCel Dura Repair
K212943 · Synthes USA Products, LLC · Jan 2022
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
Cerafix Dura Substitute
K161278 · Acera Surgical, Inc. · Aug 2016