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510(k) Data Aggregation

    K Number
    K213716
    Device Name
    InnovaBurn
    Manufacturer
    Triad Life Sciences, Inc.
    Date Cleared
    2022-09-29

    (309 days)

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

    Triad Life Sciences, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    InnovaBurn™ is indicated for the management of wounds including; partial- and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled / undermined wounds (donor sites/ grafts, post Mohs surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, and skin tears), partial-thickness second degree burns, and draining wounds. The device is intended for one-time use.
    Device Description
    InnovaBurn™ is a decellularized extracellular matrix (ECM) topical wound covering derived from porcine placental tissue. Triad processes the tissue into the ECM topical wound covering. InnovaBurn" is composed of collagen, elastin, laminin, fibronectin, hyaluronic acid and sulfated glycosaminoglycans. The wound dressing is provided in sheets that are approximately 40-100 microns thick in sizes greater than 5 x 5cm (25cm2) up to 20 x 20cm (400cm2). They are provided as single-use, sterile wound coverings.
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    K Number
    K211902
    Device Name
    InnovaMatrix PD
    Manufacturer
    Triad Life Sciences, Inc.
    Date Cleared
    2022-09-28

    (464 days)

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

    Triad Life Sciences, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    InnovaMatrix PD is indicated for the management of wounds including: partial- and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled / undermined wounds (donor sites/grafts, post Mohs surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, and skin tears), draining wounds, and partial-thickness burns. The device is intended for one-time use.
    Device Description
    InnovaMatrix® PD is a powder manufactured from the decellularized extracellular matrix (ECM) derived from porcine placental tissue harvested according to Good Manufacturing Practices. Further treatment and final sterilization yield a particulate device prepared for the management of wounds. The particulate is meant to be deployed by the user to manage wounds of the types outlined in the Indications for Use of the device. InnovaMatrix® PD is composed of collagen, elastin, laminin, fibronectin, hyaluronic acid and sulfated glycosaminoglycans. The wound dressing is provided in a particulate form as a single-use, sterile wound covering.
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    K Number
    K210580
    Device Name
    InnovaMatrix FS
    Manufacturer
    Triad Life Sciences, Inc.
    Date Cleared
    2021-04-21

    (54 days)

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

    Triad Life Sciences, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    InnovaMatrix™ FS is indicated for the 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 Mohs surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, second-degree burns and skin tears) and draining wounds. The device is intended for one-time use.
    Device Description
    InnovaMatrix™ FS is a decellularized extracellular matrix (ECM) topical wound covering derived from porcine placental tissue. Triad processes the tissue into the ECM topical wound covering. InnovaMatrix™ FS is composed of collagen, elastin, laminin, fibronectin, hyaluronic acid and sulfated glycosaminoglycans. The wound dressing is provided in fenestrated sheets that are approximately 40-100 microns thick in sizes ranging from 2 x 2cm to 5 x 5cm. They are provided as single-use, sterile wound coverings.
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    K Number
    K193552
    Device Name
    InnovaMatrix
    Manufacturer
    Triad Life Sciences, Inc.
    Date Cleared
    2020-10-21

    (306 days)

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

    Triad Life Sciences, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    InnovaMatrix™ is indicated for the management of wounds including; partial- and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, seconddegree burns and skin tears) and draining wounds. The device is intended for one-time use.
    Device Description
    InnovaMatrix™ is a decellularized extracellular matrix (ECM) topical wound covering derived from porcine placental tissue. Triad processes the tissue into the ECM topical wound covering. InnovaMatrix™ is composed of collagen, elastin, laminin, fibronectin, hyaluronic acid and sulfated glycosaminoglycans. The wound dressing is provided in sheets that are approximately 40-100 microns thick in sizes ranging from 1 x 1cm to 5 x 5cm. They are provided as single-use, sterile wound coverings.
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