Dura Substitute
Regulation 882.5910
1510(k)s in 12 months (43 all time)
0recalls in 12 months (23 all time)
20recalls that name a 510(k)
Top companies in GXQ
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 10, 2025 | Cook Biotech, Inc. Cook Medical Biodesign Dural Graft, REF C-DUR-7X10, REF G31091, Sterile Open, Classified |
GXQ | K160869 |
| Oct 30, 2024 | Integra LifeSciences Corp. Duraform Dural Graft Implant, Size 3x3 , Model Number 80-1477US
Lot CT007694 Open, Classified |
GXQ | K152481 |
| Jul 20, 2023 | Medtronic Neurosurgery Durepair Dura Regeneration Matrix:
DUREPAIR DURA SUBSTITUTE 2 X 2, 61100;
DUREPAIR DURA SUBSTITUTE 3 X 3, 61105;
DUREPAIR DURA SUBSTITUTE 1 X 3, 61106;
DUREPAIR DURA SUBSTITUTE 4 X 5, 61110;
DUREPAIR Open, Classified |
GXQ | K161370 |
| Feb 24, 2022 | Collagen Matrix, Inc. RESODURA matrix onlay 10.0 cm x 12.5 cm - indicated as dural substitutes for the repair of dura matter.
REF: DUMO10125 Terminated |
GXQ | K061487 |
| Feb 24, 2022 | Collagen Matrix, Inc. DuraMatrix-Onlay Collagen Dura Substitute Membrane 4 inches x 5 inches (10.0cm x 12.5cm)
REF: CDSLM45 Terminated |
GXQ | K061487 |
| Dec 8, 2015 | Synthes (USA) Products LLC SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute
Device listing number: D140596, D211012
SYNTHECEL Dura Repair is intended for use as a dura replacement f Terminated |
GXQ | K113071 K131792 |
| Dec 8, 2015 | Synthes (USA) Products LLC SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute
Device listing number: D140596, D211012
SYNTHECEL Dura Repair is intended for use as a dura replacement f Terminated |
GXQ | K113071 K131792 |
| Dec 8, 2015 | Synthes (USA) Products LLC SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute
Device listing number: D140596, D211012
SYNTHECEL Dura Repair is intended for use as a dura replacement f Terminated |
GXQ | K113071 K131792 |
| Dec 8, 2015 | Synthes (USA) Products LLC SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute
Device listing number: D140596, D211012
SYNTHECEL Dura Repair is intended for use as a dura replacement f Terminated |
GXQ | K113071 K131792 |
| Dec 8, 2015 | Synthes (USA) Products LLC SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute
Device listing number: D140596, D211012
SYNTHECEL Dura Repair is intended for use as a dura replacement f Terminated |
GXQ | K113071 K131792 |
| Nov 18, 2013 | Synovis Surgical Innovations, Inc. Dura Guard, Dural Repair Patch with Apex Processing.
For use as a dura substitute for the closure of dura mater during neurosurgery.
Product Code:
DG0209SN
DG0209SN
DG0209SN
DG0209SN
DG02 Terminated |
GXQ | K982282 |
| May 10, 2013 | Integra LifeSciences Corporation Layershield Adhesion Barrier Matrix
Layershield Adhesion Barrier Matrix is an absorbable implant for use as an adhesion barrier for the reduction of peridural fibrosis. Terminated |
GXQ | None listed |
| May 10, 2013 | Integra LifeSciences Corporation DuraGen XS Dural Regeneration Matrix
DuraGen XS Dural Regenerative Matrix is an absorbable implant for repair of dural defects. DuraGen XS is an easy to handle, soft, white, pliable, non-friable, por Terminated |
GXQ | K072207 |
| May 10, 2013 | Integra LifeSciences Corporation DuraGen Plus Dural Regeneration Matrix
DuraGen Plus Adhesion Barrier Matrix is an absorbable implant for repair and restoration of dural defects and as an adhesion barrier for the reduction of peridu Terminated |
GXQ | K032693 |
| May 10, 2013 | Integra LifeSciences Corporation Suturable DuraGen Dural Regenerative Matrix
Suturable DuraGen Dural Regenerative Matrix is an absorbable implant for repair of dural defects. Suturable DuraGen is an easy to handle, soft, white, plia Terminated |
GXQ | K043427 |
| May 10, 2013 | Integra LifeSciences Corporation Dural Graft Matrix
DuraGen Dural Graft Matrix is an absorbable implant for repair of dural defects. DuraGen matrix is an easy to handle, soft, white, pliable, nonfriable, porous collagen matrix. Dur Terminated |
GXQ | K982180 |
| Nov 24, 2010 | Integra LifeSciences Corp. DuraGen XS Dural Regeneration Matrix: 1 inch x 3 inches.
Non Pyrogenic; Rx only;Integra LifeSciences Corporation, Plainsboro, NJ 08536 USA
DuraGen XS is indicated as a dural substitute for repair of d Terminated |
GXQ | None listed |
| Nov 24, 2010 | Integra LifeSciences Corp. DuraGen XS Dural Regeneration Matrix: 5 inches x 7 inches.
Non Pyrogenic; Rx only;Integra LifeSciences Corporation, Plainsboro, NJ 08536 USA
DuraGen XS is indicated as a dural substitute for repair of Terminated |
GXQ | K072207 |
| Nov 24, 2010 | Integra LifeSciences Corp. DuraGen XS Dural Regeneration Matrix: 4 inches x 5 inches.
Non Pyrogenic; Rx only;Integra LifeSciences Corporation, Plainsboro, NJ 08536 USA
DuraGen XS is indicated as a dural substitute for repair of Terminated |
GXQ | K072207 |
| Nov 24, 2010 | Integra LifeSciences Corp. DuraGen XS Dural Regeneration Matrix: 3 inches x 3 inches.
Non Pyrogenic; Rx only;Integra LifeSciences Corporation, Plainsboro, NJ 08536 USA
DuraGen XS is indicated as a dural substitute for repair of Terminated |
GXQ | K072207 |
| Nov 24, 2010 | Integra LifeSciences Corp. DuraGen XS Dural Regeneration Matrix: 2 inches x 2 inches.
Non Pyrogenic; Rx only;Integra LifeSciences Corporation, Plainsboro, NJ 08536 USA
DuraGen XS is indicated as a dural substitute for repair of Terminated |
GXQ | K072207 |
| Mar 11, 2010 | Integra LifeSciences Corp Suturable DuraGen Dural Regeneration Matrix;
Non-Pyrogenic;
Sterility guaranteed unless package is damaged or opened. Rx only.
Manufacturer: Integra LifeSciences Corporation, Plainsboro, NJ 08536
Sut Terminated |
GXQ | K043427 |
| Jul 20, 2004 | Shelhigh Inc EnDura No-React Dural Substitute. Product comes in different sizes (2x10, 4x4, 5x6, 6x10, 10x12, and 12 cm diameters), sterile, stored in 2% benzyl alcohol, and distributed by Integra NeuroSciences, Terminated |
GXQ | None listed |
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