GXQ · Dura Substitute
Neurology · 21 CFR 882.5910 · Class 2
Overview
| Product Code | GXQ |
|---|---|
| Device Name | Dura Substitute |
| Regulation | 21 CFR 882.5910 |
| Device Class | Class 2 |
| Review Panel | Neurology |
| 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 | Collagen Dura Regeneration Membrane - Repair | Collagen Matrix, Inc. | Nov 18, 2025 | SESE |
| K250420 | Helios Dura Regeneration Matrix | Helios Biomedical, Inc. | May 14, 2025 | SESE |
| K223445 | ArtiFascia | Nurami Medical , Ltd. | Aug 10, 2023 | SESE |
| K212943 | SyntheCel Dura Repair | Synthes (USA) Products, LLC | Jan 28, 2022 | SESE |
| K183513 | XenoSure Dura Biologic Patch | LeMaitre Vascular, Inc. | Jun 13, 2019 | SESE |
| K172603 | Cerafix Dura Substitute | Acera Surgical, Inc. | Nov 27, 2017 | SESE |
| K163456 | DuraGen Secure Dural Regeneration Matrix | Integra LifeSciences Corporation | Jan 6, 2017 | SESE |
| K161370 | Durepair Dura Regeneration Matrix | Medtronic Neurosurgery | Nov 2, 2016 | SESE |
| K161278 | Cerafix Dura Substitute | Acera Surgical, Inc. | Aug 8, 2016 | SESE |
| K153613 | Cerafix Dura Substitute | Acera Surgical, Inc. | Mar 16, 2016 | SESE |
| K150825 | Collagen Dural Regeneration Matrix | Collagen Matrix, Inc. | Nov 20, 2015 | SESE |
| K152481 | DURAFORM Dural Graft Implant | Codman & Shurtleff, Inc. | Oct 30, 2015 | SESE |
| K141608 | COLLAGEN DURA MEMBRANE | Collagen Matrix, Inc. | Jan 16, 2015 | SESE |
| K132850 | BOVINE PERICARDIUM SUTURABLE DURAL GRAFT, TUTOPATCH DM GRAFT, TUTOPLAST BOVINE PERICARDIUM DM | Rti Surgical, Inc. | Mar 31, 2014 | SESE |
| K131792 | SYNTHECEL DURA REPAIR, SYNTHECEL DURA ONLAY | Synthes, Inc. | Dec 16, 2013 | SESE |
| K131015 | BIODESIGN ONLAY DURAL GRAFT OR BIODESIGN DURAPLASTY GRAFT | Cook Biotech, Inc. | Oct 8, 2013 | SESE |
| K122791 | LYOPLANT ONLAY | Aesculap, Inc. | Jun 4, 2013 | SESE |
| K120600 | DURAGEN SECURE DURAL REGNERATION MATRIX | Integra Life Sciences | Jun 15, 2012 | SESE |
| K113071 | SYNTHECEL DURA REPLACEMENT DEVICES | Synthes | Jan 9, 2012 | SESE |
| K092388 | 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
