FDA Product Code
FDA Product Code GXQ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Neurology
- 21 CFR Citation
- 882.5910
510(k) Clearances — 43 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K251191 | Collagen Dura Regeneration Membrane - Repair | Collagen Matrix, Inc. | 2025-11-18 | Traditional | PDF ↗ |
| K250420 | Helios Dura Regeneration Matrix | Helios Biomedical, Inc. | 2025-05-14 | Traditional | PDF ↗ |
| K223445 | ArtiFascia | Nurami Medical , Ltd. | 2023-08-10 | Traditional | PDF ↗ |
| K212943 | SyntheCel Dura Repair | Synthes (USA) Products, LLC | 2022-01-28 | Traditional | PDF ↗ |
| K183513 | XenoSure Dura Biologic Patch | LeMaitre Vascular, Inc. | 2019-06-13 | Traditional | PDF ↗ |
| K172603 | Cerafix Dura Substitute | Acera Surgical, Inc. | 2017-11-27 | Traditional | PDF ↗ |
| K163456 | DuraGen Secure Dural Regeneration Matrix | Integra LifeSciences Corporation | 2017-01-06 | Special | PDF ↗ |
| K161370 | Durepair Dura Regeneration Matrix | Medtronic Neurosurgery | 2016-11-02 | Traditional | PDF ↗ |
| K161278 | Cerafix Dura Substitute | Acera Surgical, Inc. | 2016-08-08 | Traditional | PDF ↗ |
| K153613 | Cerafix Dura Substitute | Acera Surgical, Inc. | 2016-03-16 | Traditional | PDF ↗ |
| K150825 | Collagen Dural Regeneration Matrix | Collagen Matrix, Inc. | 2015-11-20 | Traditional | PDF ↗ |
| K152481 | DURAFORM Dural Graft Implant | Codman & Shurtleff, Inc. | 2015-10-30 | Special | PDF ↗ |
| K141608 | COLLAGEN DURA MEMBRANE | Collagen Matrix, Inc. | 2015-01-16 | Traditional | PDF ↗ |
| K132850 | BOVINE PERICARDIUM SUTURABLE DURAL GRAFT, TUTOPATCH DM GRAFT, TUTOPLAST BOVINE PERICARDIUM DM | Rti Surgical, Inc. | 2014-03-31 | Traditional | PDF ↗ |
| K131792 | SYNTHECEL DURA REPAIR, SYNTHECEL DURA ONLAY | Synthes, Inc. | 2013-12-16 | Traditional | PDF ↗ |
| K131015 | BIODESIGN ONLAY DURAL GRAFT OR BIODESIGN DURAPLASTY GRAFT | Cook Biotech, Inc. | 2013-10-08 | Traditional | PDF ↗ |
| K122791 | LYOPLANT ONLAY | Aesculap, Inc. | 2013-06-04 | Traditional | PDF ↗ |
| K120600 | DURAGEN SECURE DURAL REGNERATION MATRIX | Integra Life Sciences | 2012-06-15 | Traditional | PDF ↗ |
| K113071 | SYNTHECEL DURA REPLACEMENT DEVICES | Synthes | 2012-01-09 | Traditional | PDF ↗ |
| K092388 | DURAGEN PLUS DURAL REGENERATION MATRIX- SPINAL MATRIX, MODEL DP2013SM, INTEGRA SPINAL MEND DURAL REGENERATION MATRIX, MO | Integra LifeSciences Corporation | 2010-01-21 | Traditional | PDF ↗ |
| K072207 | DURAGEN XS DURAL REGENERATION MATRIX | Integra Lifesciences Corp. | 2007-08-23 | Special | PDF ↗ |
| K061208 | LIFECELL DURAL SUBSTITUTE MATRIX | Lifecell Corp. | 2007-01-03 | Traditional | PDF ↗ |
| K063117 | MODIFICATION TO DUREPAIR DURA REGENERATION MATRIX | Medtronic Neurosurgery | 2006-11-03 | Special | PDF ↗ |
| K061487 | DURAMATRIX COLLAGEN DURA SUBSTITUTE MEMBRANE - ONLAY AND SUTURABLE | Collagen Matrix, Inc. | 2006-06-26 | Special | PDF ↗ |
| K052211 | DUREPAIR DURA REGENERATION MATRIX | Medtronic Neurosurgery | 2005-09-14 | Special | PDF ↗ |
| K043427 | DURAGEN II DURAL REGENERATION MATRIX | Integra Lifesciences Corp. | 2005-01-12 | Special | PDF ↗ |
| K040888 | DURAMATRIX COLLAGEN DURA SUBSTITUTE MEMBRANE | Collagen Matrix, Inc. | 2004-12-01 | Traditional | PDF ↗ |
| K041000 | DUREPAIR DURA REGENERATION MATRIX | Medtronic Neurosurgery | 2004-07-27 | Traditional | PDF ↗ |
| K041518 | CODMAN DURAFORM DURAL GRAFT IMPLANT | Codman & Shurtleff, Inc. | 2004-06-22 | Special | PDF ↗ |
| K032693 | DURAGEN PLUS DURAL GRAFT MATRIX | Integra Lifesciences Corp. | 2003-09-30 | Special | PDF ↗ |
| K031850 | DURASIS DURAL SUBSTITUTE | Cook Biotech, Inc. | 2003-09-08 | Traditional | PDF ↗ |
| K021477 | PRECLUDE MVP DURA SUBSTITUTE | W. L. Gore & Associates, Inc. | 2002-11-08 | Traditional | PDF ↗ |
| K982101 | SHELHIGH NO-REACT DURA SHIELD | Shelhigh, Inc. | 2000-05-02 | Traditional | PDF ↗ |
| K991413 | CODMAN ETHISORB DURA PATCH | Johnson & Johnson Professionals, Inc. | 2000-03-13 | Traditional | PDF ↗ |
| K982180 | DURAGEN DURAL GRAFT MATRIX | Integra Lifesciences Corp. | 1999-07-06 | Traditional | PDF ↗ |
| K984534 | PRECLUDE ACUSEAL DURA SUBSTITUTE | W. L. Gore & Associates, Inc. | 1999-03-15 | Traditional | PDF ↗ |
| K982282 | DURA-GUARD - DURAL REPAIR PATCH | Bio-Vascular, Inc. | 1998-07-30 | Special | PDF ↗ |
| K980548 | DURA-PATCH MODEL DP-XXX | Bridger Biomed, Inc. | 1998-05-13 | Traditional | PDF ↗ |
| K973706 | DURA-GUARD-DURAL REPAIR PATCH | Bio-Vascular, Inc. | 1997-12-24 | Traditional | PDF ↗ |
| K970851 | LYOPLANT DURA SUBSTITUTE(VARIOUS) | Aesculap, Inc. | 1997-12-09 | Traditional | PDF ↗ |
| K960470 | NEURO-PATCH | Aesculap, Inc. | 1996-05-10 | Traditional | PDF ↗ |
| K953969 | PRECLUDE DURA SUBSTITUTE | W. L. Gore & Associates, Inc. | 1995-11-01 | Traditional | PDF ↗ |
| K950956 | DURA-GUARD DURAL REPAIR PATCH, DURA-GUARD DURA SUBSTITUTE | Bio-Vascular, Inc. | 1995-06-02 | Traditional | PDF ↗ |
Product code GXQ · Class II · Neurology. Data: openFDA.