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Dura Substitute

FDA product code GXQ · 39 cleared devices

Class 2 Neurology

Regulation: 21 CFR 882.5910
Review panel: NE
Implant: Yes
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1995-06-02 – 2025-11-18

GXQ 2025-11-18

Collagen Dura Regeneration Membrane - Repair

Applicant Collagen Matrix, Inc.

K number K251191

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GXQ 2025-05-14

Helios Dura Regeneration Matrix

Applicant Helios Biomedical, Inc.

K number K250420

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GXQ 2023-08-10

ArtiFascia

Applicant Nurami Medical , Ltd.

K number K223445

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GXQ 2022-01-28

SyntheCel Dura Repair

Applicant Synthes (USA) Products, LLC

K number K212943

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GXQ 2019-06-13

XenoSure Dura Biologic Patch

Applicant LeMaitre Vascular, Inc.

K number K183513

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GXQ 2017-11-27

Cerafix Dura Substitute

Applicant Acera Surgical, Inc.

K number K172603

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GXQ 2017-01-06

DuraGen Secure Dural Regeneration Matrix

Applicant Integra LifeSciences Corporation

K number K163456

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GXQ 2016-11-02

Durepair Dura Regeneration Matrix

Applicant Medtronic Neurosurgery

K number K161370

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GXQ 2016-08-08

Cerafix Dura Substitute

Applicant Acera Surgical, Inc.

K number K161278

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GXQ 2016-03-16

Cerafix Dura Substitute

Applicant Acera Surgical, Inc.

K number K153613

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GXQ 2013-12-16

SYNTHECEL DURA REPAIR, SYNTHECEL DURA ONLAY

Applicant Synthes, Inc.

K number K131792

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GXQ 2013-10-08

BIODESIGN ONLAY DURAL GRAFT OR BIODESIGN DURAPLASTY GRAFT

Applicant Cook Biotech, Inc.

K number K131015

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GXQ 2013-06-04

LYOPLANT ONLAY

Applicant Aesculap, Inc.

K number K122791

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GXQ 2012-06-15

DURAGEN SECURE DURAL REGNERATION MATRIX

Applicant Integra Life Sciences

K number K120600

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GXQ 2012-01-09

SYNTHECEL DURA REPLACEMENT DEVICES

Applicant Synthes

K number K113071

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GXQ 2010-01-21

DURAGEN PLUS DURAL REGENERATION MATRIX- SPINAL MATRIX, MODEL DP2013SM, INTEGRA SPINAL MEND DURAL REGENERATION MATRIX, MO

Applicant Integra LifeSciences Corporation

K number K092388

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GXQ 2007-08-23

DURAGEN XS DURAL REGENERATION MATRIX

Applicant Integra Lifesciences Corp.

K number K072207

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GXQ 2007-01-03

LIFECELL DURAL SUBSTITUTE MATRIX

Applicant Lifecell Corp.

K number K061208

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GXQ 2006-11-03

MODIFICATION TO DUREPAIR DURA REGENERATION MATRIX

Applicant Medtronic Neurosurgery

K number K063117

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GXQ 2006-06-26

DURAMATRIX COLLAGEN DURA SUBSTITUTE MEMBRANE - ONLAY AND SUTURABLE

Applicant Collagen Matrix, Inc.

K number K061487

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GXQ 2005-09-14

DUREPAIR DURA REGENERATION MATRIX

Applicant Medtronic Neurosurgery

K number K052211

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GXQ 2005-01-12

DURAGEN II DURAL REGENERATION MATRIX

Applicant Integra Lifesciences Corp.

K number K043427

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GXQ 2004-12-01

DURAMATRIX COLLAGEN DURA SUBSTITUTE MEMBRANE

Applicant Collagen Matrix, Inc.

K number K040888

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GXQ 2004-07-27

DUREPAIR DURA REGENERATION MATRIX

Applicant Medtronic Neurosurgery

K number K041000

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GXQ 2004-06-22

CODMAN DURAFORM DURAL GRAFT IMPLANT

Applicant Codman & Shurtleff, Inc.

K number K041518

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GXQ 2003-09-30

DURAGEN PLUS DURAL GRAFT MATRIX

Applicant Integra Lifesciences Corp.

K number K032693

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GXQ 2003-09-08

DURASIS DURAL SUBSTITUTE

Applicant Cook Biotech, Inc.

K number K031850

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GXQ 2002-11-08

PRECLUDE MVP DURA SUBSTITUTE

Applicant W. L. Gore & Associates, Inc.

K number K021477

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GXQ 2000-05-02

SHELHIGH NO-REACT DURA SHIELD

Applicant Shelhigh, Inc.

K number K982101

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GXQ 2000-03-13

CODMAN ETHISORB DURA PATCH

Applicant Johnson & Johnson Professionals, Inc.

K number K991413

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GXQ 1999-07-06

DURAGEN DURAL GRAFT MATRIX

Applicant Integra Lifesciences Corp.

K number K982180

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GXQ 1999-03-15

PRECLUDE ACUSEAL DURA SUBSTITUTE

Applicant W. L. Gore & Associates, Inc.

K number K984534

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GXQ 1998-07-30

DURA-GUARD - DURAL REPAIR PATCH

Applicant Bio-Vascular, Inc.

K number K982282

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GXQ 1998-05-13

DURA-PATCH MODEL DP-XXX

Applicant Bridger Biomed, Inc.

K number K980548

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GXQ 1997-12-24

DURA-GUARD-DURAL REPAIR PATCH

Applicant Bio-Vascular, Inc.

K number K973706

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GXQ 1997-12-09

LYOPLANT DURA SUBSTITUTE(VARIOUS)

Applicant Aesculap, Inc.

K number K970851

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GXQ 1996-05-10

NEURO-PATCH

Applicant Aesculap, Inc.

K number K960470

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GXQ 1995-11-01

PRECLUDE DURA SUBSTITUTE

Applicant W. L. Gore & Associates, Inc.

K number K953969

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GXQ 1995-06-02

DURA-GUARD DURAL REPAIR PATCH, DURA-GUARD DURA SUBSTITUTE

Applicant Bio-Vascular, Inc.

K number K950956

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