Product code GXQ
- Device name
- Dura Substitute
- Medical specialty
- Neurology
- Device class
- 2
- Regulation number
- 882.5910
- Review panel
- NE
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251191 | Collagen Dura Regeneration Membrane - Repair | Collagen Matrix, Inc. | 2025-11-18 |
| K250420 | Helios Dura Regeneration Matrix | Helios Biomedical, Inc. | 2025-05-14 |
| K223445 | ArtiFascia | Nurami Medical , Ltd. | 2023-08-10 |
| K212943 | SyntheCel Dura Repair | Synthes (USA) Products, LLC | 2022-01-28 |
| K183513 | XenoSure Dura Biologic Patch | LeMaitre Vascular, Inc. | 2019-06-13 |
| K172603 | Cerafix Dura Substitute | Acera Surgical, Inc. | 2017-11-27 |
| K163456 | DuraGen Secure Dural Regeneration Matrix | Integra LifeSciences Corporation | 2017-01-06 |
| K161370 | Durepair Dura Regeneration Matrix | Medtronic Neurosurgery | 2016-11-02 |
| K161278 | Cerafix Dura Substitute | Acera Surgical, Inc. | 2016-08-08 |
| K153613 | Cerafix Dura Substitute | Acera Surgical, Inc. | 2016-03-16 |
| K150825 | Collagen Dural Regeneration Matrix | Collagen Matrix, Inc. | 2015-11-20 |
| K152481 | DURAFORM Dural Graft Implant | Codman & Shurtleff, Inc. | 2015-10-30 |
| K141608 | COLLAGEN DURA MEMBRANE | Collagen Matrix, Inc. | 2015-01-16 |
| K132850 | BOVINE PERICARDIUM SUTURABLE DURAL GRAFT, TUTOPATCH DM GRAFT, TUTOPLAST BOVINE PERICARDIUM DM | Rti Surgical, Inc. | 2014-03-31 |
| K131792 | SYNTHECEL DURA REPAIR, SYNTHECEL DURA ONLAY | Synthes, Inc. | 2013-12-16 |
| K131015 | BIODESIGN ONLAY DURAL GRAFT OR BIODESIGN DURAPLASTY GRAFT | Cook Biotech, Inc. | 2013-10-08 |
| K122791 | LYOPLANT ONLAY | Aesculap, Inc. | 2013-06-04 |
| K120600 | DURAGEN SECURE DURAL REGNERATION MATRIX | Integra Life Sciences | 2012-06-15 |
| K113071 | SYNTHECEL DURA REPLACEMENT DEVICES | Synthes | 2012-01-09 |
| K092388 | DURAGEN PLUS DURAL REGENERATION MATRIX- SPINAL MATRIX, MODEL DP2013SM, INTEGRA SPINAL MEND DURAL REGENERATION MATRIX, MO | Integra LifeSciences Corporation | 2010-01-21 |
| K072207 | DURAGEN XS DURAL REGENERATION MATRIX | Integra Lifesciences Corp. | 2007-08-23 |
| K061208 | LIFECELL DURAL SUBSTITUTE MATRIX | Lifecell Corp. | 2007-01-03 |
| K063117 | MODIFICATION TO DUREPAIR DURA REGENERATION MATRIX | Medtronic Neurosurgery | 2006-11-03 |
| K061487 | DURAMATRIX COLLAGEN DURA SUBSTITUTE MEMBRANE - ONLAY AND SUTURABLE | Collagen Matrix, Inc. | 2006-06-26 |
| K052211 | DUREPAIR DURA REGENERATION MATRIX | Medtronic Neurosurgery | 2005-09-14 |
| K043427 | DURAGEN II DURAL REGENERATION MATRIX | Integra Lifesciences Corp. | 2005-01-12 |
| K040888 | DURAMATRIX COLLAGEN DURA SUBSTITUTE MEMBRANE | Collagen Matrix, Inc. | 2004-12-01 |
| K041000 | DUREPAIR DURA REGENERATION MATRIX | Medtronic Neurosurgery | 2004-07-27 |
| K041518 | CODMAN DURAFORM DURAL GRAFT IMPLANT | Codman & Shurtleff, Inc. | 2004-06-22 |
| K032693 | DURAGEN PLUS DURAL GRAFT MATRIX | Integra Lifesciences Corp. | 2003-09-30 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10381780541417 | Durepair® | Integra Lifesciences Corporation | 2026-03-11 |
| 10381780541400 | Durepair® | Integra Lifesciences Corporation | 2026-03-11 |
| 10381780541387 | Durepair® | Integra Lifesciences Corporation | 2026-03-11 |
| 10381780540762 | Durepair™ | TEI BIOSCIENCES INC. | 2025-01-31 |
| 10381780511373 | Integra® DuraFlex® | Integra Lifesciences Corporation | 2019-02-22 |
| 10381780511366 | Integra® DuraFlex® | Integra Lifesciences Corporation | 2019-02-22 |
| 10381780511359 | Integra® DuraFlex® | Integra Lifesciences Corporation | 2019-02-22 |
| 10381780511335 | Integra® DuraFlex® | Integra Lifesciences Corporation | 2019-02-22 |
| 10381780511342 | Integra® DuraFlex® | Integra Lifesciences Corporation | 2019-02-22 |
| 10886704079484 | DURAFORM | Cerenovus, Inc. | 2016-03-22 |
| 10886704079460 | DURAFORM | Cerenovus, Inc. | 2016-03-22 |
| 10886704079446 | DURAFORM | Cerenovus, Inc. | 2016-03-22 |
| 10886704079422 | DURAFORM | Cerenovus, Inc. | 2016-03-22 |
| 10381780023562 | DuraGen® | Integra Lifesciences Corporation | 2015-09-22 |
| 10381780070948 | DuraGen® Plus | Integra Lifesciences Corporation | 2015-09-22 |
| 10381780070931 | DuraGen® Plus | Integra Lifesciences Corporation | 2015-09-22 |
| 10381780070924 | DuraGen® Plus | Integra Lifesciences Corporation | 2015-09-22 |
| 10381780070917 | DuraGen® Plus | Integra Lifesciences Corporation | 2015-09-22 |
| 10381780023609 | DuraGen® | Integra Lifesciences Corporation | 2015-09-22 |
| 10381780023586 | DuraGen® | Integra Lifesciences Corporation | 2015-09-22 |
| 10381780023548 | DuraGen® | Integra Lifesciences Corporation | 2015-09-22 |
| 10886704036678 | DURAFORM | Cerenovus, Inc. | 2015-09-20 |
| 10886704036692 | DURAFORM | Cerenovus, Inc. | 2015-09-20 |
| 10886704036715 | DURAFORM | Cerenovus, Inc. | 2015-09-20 |
| 10886704036739 | DURAFORM | Cerenovus, Inc. | 2015-09-20 |
| 10887587001357 | SyntheCel | Synthes GmbH | 2015-09-14 |
| 10381780032519 | DuraGen® Secure | Integra Lifesciences Corporation | 2015-07-31 |
| 10381780032502 | DuraGen® Secure | Integra Lifesciences Corporation | 2015-07-31 |
| 10381780032496 | DuraGen® Secure | Integra Lifesciences Corporation | 2015-07-31 |
| 10381780032489 | DuraGen® Secure | Integra Lifesciences Corporation | 2015-07-31 |