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Found 40 results
510(k) Data Aggregation
K Number
K250420Device Name
Helios Dura Regeneration Matrix
Manufacturer
Helios Biomedical Inc.
Date Cleared
2025-05-14
(90 days)
Product Code
GXQ
Regulation Number
882.5910Why 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
K223445Device Name
ArtiFascia
Manufacturer
Nurami Medical Ltd.
Date Cleared
2023-08-10
(269 days)
Product Code
GXQ
Regulation Number
882.5910Why 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
K212943Device Name
SyntheCel Dura Repair
Manufacturer
Synthes (USA) products, LLC
Date Cleared
2022-01-28
(135 days)
Product Code
GXQ
Regulation Number
882.5910Why 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
K183513Device Name
XenoSure Dura Biologic Patch
Manufacturer
LeMaitre Vascular Inc.
Date Cleared
2019-06-13
(177 days)
Product Code
GXQ
Regulation Number
882.5910Why 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
K172603Device Name
Cerafix Dura Substitute
Manufacturer
Acera Surgical, Inc.
Date Cleared
2017-11-27
(89 days)
Product Code
GXQ
Regulation Number
882.5910Why 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
K163456Device Name
DuraGen Secure Dural Regeneration Matrix
Manufacturer
INTEGRA LIFESCIENCES CORPORATION
Date Cleared
2017-01-06
(28 days)
Product Code
GXQ
Regulation Number
882.5910Why 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
K161370Device Name
Durepair Dura Regeneration Matrix
Manufacturer
Medtronic Neurosurgery
Date Cleared
2016-11-02
(169 days)
Product Code
GXQ
Regulation Number
882.5910Why 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
K161278Device Name
Cerafix Dura Substitute
Manufacturer
ACERA SURGICAL, INC.
Date Cleared
2016-08-08
(94 days)
Product Code
GXQ
Regulation Number
882.5910Why 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
K153613Device Name
Cerafix Dura Substitute
Manufacturer
ACERA SURGICAL, INC.
Date Cleared
2016-03-16
(90 days)
Product Code
GXQ
Regulation Number
882.5910Why 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
K150825Device Name
Collagen Dural Regeneration Matrix
Manufacturer
COLLAGEN MATRIX, INC.
Date Cleared
2015-11-20
(238 days)
Product Code
GXQ
Regulation Number
882.5910Why 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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