LogoFDA 510(k) Search
Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K210024
    Device Name
    NeoMatriX Wound Matrix
    Manufacturer
    NeXtGen Biologics, Inc.
    Date Cleared
    2021-10-07

    (276 days)

    Product Code
    KGN
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    NeXtGen Biologics, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    NeoMatriX® Wound Matrix is intended for management of wounds including: - . Partial and full-thickness wounds, - Pressure ulcers, - . Venous ulcers, - Diabetic ulcers, - Chronic vascular ulcers, - . Tunneled/undermined wounds, - Surgical wounds (donor sites/grafts, Moh's surgery, post-laser surgery, podiatric, and wound dehiscience), ● - Trauma wounds (abrasions, lacerations, partial thickness burns, and skin tears), ● - Draining wounds. The device is intended for one-time use.
    Device Description
    NeoMatriX Wound Matrix is a sterile, wound dressing fabricated from the dermal extracellular matrix of axolotl. This device is derived from an amphibian farm-raised hybrid axolot! source from a closed herd in a dedicated facility. NeoMatriX is provided as sheets of various sizes for placement on wound beds to help manage the wound environment. This device is terminally sterilized using gamma irradiation. NeoMatriX wound matrix provides an adherent covering that protects the wound from the environment. The device is intended for one time use.
    Ask a Question

    Ask a specific question about this device

    K Number
    K181330
    Device Name
    NeoMatriX Wound Matrix
    Manufacturer
    NeXtGen Biologics, Inc.
    Date Cleared
    2018-10-11

    (146 days)

    Product Code
    KGN
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    NeXtGen Biologics, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    NeoMatriX® Wound Matrix is intended for management of wounds, including: - · Partial and full-thickness wounds, - · Pressure ulcers, - Venous ulcers, - · Diabetic ulcers. - · Chronic vascular ulcers, - · Tunneled / undermined wounds, - · Surgical wounds (donor sites / grafts, post Moh's surgery, post-laser surgery, podiatric, and wound dehiscence), - · Trauma wounds (abrasions, lacerations, second-degree burns, and skin tears), - Draining wounds. The device is intended for one-time use.
    Device Description
    NeoMatriX Wound Matrix is a sterile, wound dressing fabricated from the dermal extracellular matrix of axolotl. This device is derived from an amphibian farm-raised hybrid axolot! source from a closed herd in a dedicated facility. NeoMatriX is provided as sheets of various sizes for placement on wound beds to help manage the wound environment. This device is terminally sterilized using gamma irradiation. NeoMatriX wound matrix provides an adherent covering that protects the wound from the environment. The device is intended for one time use.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1