Browse hierarchy: [Neurology (NE)](/submissions/NE) → [Subpart F — Neurological Therapeutic Devices](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices) → [21 CFR 882.5910](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/882.5910) → GXQ — Dura Substitute # GXQ · Dura Substitute _Neurology · 21 CFR 882.5910 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GXQ ## Overview - **Product Code:** GXQ - **Device Name:** Dura Substitute - **Regulation:** [21 CFR 882.5910](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/882.5910) - **Device Class:** 2 - **Review Panel:** [Neurology](/submissions/NE) - **Implant:** yes ## Identification A dura substitute is a sheet or material that is used to repair the dura mater (the membrane surrounding the brain). ## Classification Rationale Class II (performance standards). ## Recent Cleared Devices (20 of 43) Showing 20 most recent of 43 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K251191](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GXQ/K251191.md) | Collagen Dura Regeneration Membrane - Repair | Collagen Matrix, Inc. | Nov 18, 2025 | SESE | | [K250420](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GXQ/K250420.md) | Helios Dura Regeneration Matrix | Helios Biomedical, Inc. | May 14, 2025 | SESE | | [K223445](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GXQ/K223445.md) | ArtiFascia | Nurami Medical , Ltd. | Aug 10, 2023 | SESE | | [K212943](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GXQ/K212943.md) | SyntheCel Dura Repair | Synthes (USA) Products, LLC | Jan 28, 2022 | SESE | | [K183513](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GXQ/K183513.md) | XenoSure Dura Biologic Patch | LeMaitre Vascular, Inc. | Jun 13, 2019 | SESE | | [K172603](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GXQ/K172603.md) | Cerafix Dura Substitute | Acera Surgical, Inc. | Nov 27, 2017 | SESE | | [K163456](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GXQ/K163456.md) | DuraGen Secure Dural Regeneration Matrix | Integra LifeSciences Corporation | Jan 6, 2017 | SESE | | [K161370](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GXQ/K161370.md) | Durepair Dura Regeneration Matrix | Medtronic Neurosurgery | Nov 2, 2016 | SESE | | [K161278](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GXQ/K161278.md) | Cerafix Dura Substitute | Acera Surgical, Inc. | Aug 8, 2016 | SESE | | [K153613](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GXQ/K153613.md) | Cerafix Dura Substitute | Acera Surgical, Inc. | Mar 16, 2016 | SESE | | [K150825](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GXQ/K150825.md) | Collagen Dural Regeneration Matrix | Collagen Matrix, Inc. | Nov 20, 2015 | SESE | | [K152481](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GXQ/K152481.md) | DURAFORM Dural Graft Implant | Codman & Shurtleff, Inc. | Oct 30, 2015 | SESE | | [K141608](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GXQ/K141608.md) | COLLAGEN DURA MEMBRANE | Collagen Matrix, Inc. | Jan 16, 2015 | SESE | | [K132850](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GXQ/K132850.md) | BOVINE PERICARDIUM SUTURABLE DURAL GRAFT, TUTOPATCH DM GRAFT, TUTOPLAST BOVINE PERICARDIUM DM | Rti Surgical, Inc. | Mar 31, 2014 | SESE | | [K131792](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GXQ/K131792.md) | SYNTHECEL DURA REPAIR, SYNTHECEL DURA ONLAY | Synthes, Inc. | Dec 16, 2013 | SESE | | [K131015](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GXQ/K131015.md) | BIODESIGN ONLAY DURAL GRAFT OR BIODESIGN DURAPLASTY GRAFT | Cook Biotech, Inc. | Oct 8, 2013 | SESE | | [K122791](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GXQ/K122791.md) | LYOPLANT ONLAY | Aesculap, Inc. | Jun 4, 2013 | SESE | | [K120600](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GXQ/K120600.md) | DURAGEN SECURE DURAL REGNERATION MATRIX | Integra Life Sciences | Jun 15, 2012 | SESE | | [K113071](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GXQ/K113071.md) | SYNTHECEL DURA REPLACEMENT DEVICES | Synthes | Jan 9, 2012 | SESE | | [K092388](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GXQ/K092388.md) | DURAGEN PLUS DURAL REGENERATION MATRIX- SPINAL MATRIX, MODEL DP2013SM, INTEGRA SPINAL MEND DURAL REGENERATION MATRIX, MO | Integra LifeSciences Corporation | Jan 21, 2010 | SESE | ## Top Applicants - Collagen Matrix, Inc. — 5 clearances - Integra Lifesciences Corp. — 4 clearances - Medtronic Neurosurgery — 4 clearances - Acera Surgical, Inc. — 3 clearances - Aesculap, Inc. — 3 clearances --- **Source:** [https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GXQ](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GXQ) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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