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510(k) Data Aggregation

    K Number
    K250420
    Device Name
    Helios Dura Regeneration Matrix
    Manufacturer
    Helios Biomedical Inc.
    Date Cleared
    2025-05-14

    (90 days)

    Product Code
    GXQ
    Regulation Number
    882.5910
    Why did this record match?
    Product Code :

    GXQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Helios Dura Regeneration Matrix is indicated as a dura substitute for the repair of the dura mater.
    Device Description
    Helios Dura Regeneration Matrix is a collagen implant for the repair of defects in the dura mater. The single-use device is supplied sterile in sheet form in a variety of sizes ranging from 6.5 - 250 cm² (~1 - 40-in²) to be trimmed and sutured or onlayed by the surgeon to meet the individual patient's needs.
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    K Number
    K223445
    Device Name
    ArtiFascia
    Manufacturer
    Nurami Medical Ltd.
    Date Cleared
    2023-08-10

    (269 days)

    Product Code
    GXQ
    Regulation Number
    882.5910
    Why did this record match?
    Product Code :

    GXQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ArtiFascia is indicated as dura substitute for the repair of dura mater. ArtiFascia is indicated for defects of 25cm² (3.87 in²) or less in area. For example, 6 cm X 4 cm (24 cm²) would be an acceptable defect size.
    Device Description
    ArtiFascia is an absorbable dural repair graft for the repair of cranial dural defects. ArtiFascia is a highly flexible, easy to handle, non-friable soft matrix composed of synthetic non-woven fibers and a non-porous film. ArtiFascia is packaged in a single-use peelable package and is provided sterile, nonpyrogenic. ArtiFascia readily conforms to the surface of the wound area and is applied to the dural defect by using sutures.
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    K Number
    K212943
    Device Name
    SyntheCel Dura Repair
    Manufacturer
    Synthes (USA) products, LLC
    Date Cleared
    2022-01-28

    (135 days)

    Product Code
    GXQ
    Regulation Number
    882.5910
    Why did this record match?
    Product Code :

    GXQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SYNTHECEL® Dura Repair is indicated as a dura replacement for the repair of dura mater in adults.
    Device Description
    SYNTHECEL® Dura Repair is composed of biosynthesized cellulose and water with a unique construction of non-woven, interconnected cellulose fibers. SYNTHECEL® Dura Repair functions as a mechanical layer which protects and repairs the dural defect while preventing further CSF leakage. SYNTHECEL® Dura Repair is immunologically inert and has demonstrated minimal foreign body response. It is non-resorbable.
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    K Number
    K183513
    Device Name
    XenoSure Dura Biologic Patch
    Manufacturer
    LeMaitre Vascular Inc.
    Date Cleared
    2019-06-13

    (177 days)

    Product Code
    GXQ
    Regulation Number
    882.5910
    Why did this record match?
    Product Code :

    GXQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DuraSure Biologic Patch is intended for use as a surgical patch material to close dura mater during neurosurgery.
    Device Description
    The DuraSure consists of one piece of bovine pericardial tissue that has been selected for minimal tissue blemishes. The tissue is treated with a glutaraldehyde process which crosslinks the collagen fibers and minimizes antigenicity. The DuraSure is liquid chemical sterilized and packaged in a plastic jar containing sterile glutaraldehyde storage solution. The DuraSure is designed to repair the body's natural organs.
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    K Number
    K172603
    Device Name
    Cerafix Dura Substitute
    Manufacturer
    Acera Surgical, Inc.
    Date Cleared
    2017-11-27

    (89 days)

    Product Code
    GXQ
    Regulation Number
    882.5910
    Why did this record match?
    Product Code :

    GXQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Cerafix Dura Substitute is indicated as a dura substitute for the repair of dura mater. This device is indicated for defects of 4.9 in2 (31.7cm2) or less in area. For example, 4.0 in x 1.2 in (10.0 cm x 3.1 cm) would be an acceptable defect size.
    Device Description
    Cerafix® Dura Substitute is a resorbable implant for repair of dural defects. The device can be applied as an onlay matrix or sutured in place. Cerafix® Dura Substitute is a soft, white, pliable, nonfriable, porous polymer matrix. Cerafix® Dura Substitute is available in a variety of sizes and is supplied sterile and nonpyrogenic in a single-use nested pouch configuration, which is enclosed within a protective chipboard envelope.
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    K Number
    K163456
    Device Name
    DuraGen Secure Dural Regeneration Matrix
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION
    Date Cleared
    2017-01-06

    (28 days)

    Product Code
    GXQ
    Regulation Number
    882.5910
    Why did this record match?
    Product Code :

    GXQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    DuraGen® Secure Dural Regeneration Matrix is indicated as a dura substitute for the repair of dura mater.
    Device Description
    DuraGen® Secure Dural Regeneration Matrix is an absorbable implant for the repair of dura mater. This absorbable, sutureless onlay graft is comprised of a porous, highly purified collagen matrix and a thin layer of hydroxypropyl methyl cellulose (HPMC). HPMC is a non-cytotoxic, non-immunogenic, biocompatible plant-derived cellulose-based material. The addition of HPMC results in a dural graft which reduces the potential for the product to migrate, slide or displace during the surgical procedure, such as during irrigation of the surgical site or in a standing pool of fluid, without the use of sutures.
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    K Number
    K161370
    Device Name
    Durepair Dura Regeneration Matrix
    Manufacturer
    Medtronic Neurosurgery
    Date Cleared
    2016-11-02

    (169 days)

    Product Code
    GXQ
    Regulation Number
    882.5910
    Why did this record match?
    Product Code :

    GXQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Durepair is indicated as a dura substitute for the repair of the dura mater.
    Device Description
    Durepair® Dura Regeneration Matrix is a collagen implant for the repair of defects in the dura mater. Durepair is supplied sterile, in a double-peel package, and is intended for single (one-time) use-only. Durepair is available in a variety of sizes intended to be cut by the surgeon to the desired shape.
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    K Number
    K161278
    Device Name
    Cerafix Dura Substitute
    Manufacturer
    ACERA SURGICAL, INC.
    Date Cleared
    2016-08-08

    (94 days)

    Product Code
    GXQ
    Regulation Number
    882.5910
    Why did this record match?
    Product Code :

    GXQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Cerafix® Dura Substitute is indicated as a dura substitute for the repair of dura mater. This device is indicated for defects of 4.4 in2 (28.3 cm2) or less in area. For example, 4.0 in x 1.1 in (10.1 cm x 2.8 cm) would be an acceptable defect size.
    Device Description
    Cerafix® Dura Substitute is a resorbable implant for repair of dural defects and is to be used with tensionless sutures. Cerafix® Dura Substitute is a soft, white, pliable, nonfriable, porous polymer matrix. Cerafix® Dura Substitute is available in a variety of sizes and is supplied sterile and nonpyrogenic in a single-use nested pouch configuration, which is enclosed within a protective chipboard envelope.
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    K Number
    K153613
    Device Name
    Cerafix Dura Substitute
    Manufacturer
    ACERA SURGICAL, INC.
    Date Cleared
    2016-03-16

    (90 days)

    Product Code
    GXQ
    Regulation Number
    882.5910
    Why did this record match?
    Product Code :

    GXQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Cerafix® Dura Substitute is indicated as a dura substitute for the repair of dura mater. This device is indicated for defects of 1.9 in² (12.5cm²) or less in area. For example, 1.2 in x 1.6 in (3 cm x 4 cm) would be an acceptable defect size.
    Device Description
    Cerafix® Dura Substitute is a resorbable implant for repair of dural defects and is to be used with tensionless sutures. Cerafix® Dura Substitute is a soft, white, pliable, nonfriable, porous polymer matrix. Cerafix® Dura Substitute is available in a variety of sizes and is supplied sterile and nonpyrogenic in a single-use nested pouch configuration, which is enclosed within a protective chipboard envelope.
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    K Number
    K150825
    Device Name
    Collagen Dural Regeneration Matrix
    Manufacturer
    COLLAGEN MATRIX, INC.
    Date Cleared
    2015-11-20

    (238 days)

    Product Code
    GXQ
    Regulation Number
    882.5910
    Why did this record match?
    Product Code :

    GXQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Collagen Dural Regeneration Matrix is intended for use as a dura substitute for the repair of dura mater.
    Device Description
    Collagen Dural Regeneration Matrix is a white, non-friable, resorbable and biocompatible type I collagen matrix made from purified bovine Achilles tendon. Collagen Dural Regeneration Matrix is a porous, sponge-like collagen matrix with one smooth surface that conforms to the contours of the defect site. It is supplied sterile, non-pyrogenic, in various sizes, and for single use only.
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