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510(k) Data Aggregation

    K Number
    K233378
    Device Name
    ABCcolla® Collagen ADM Scaffold
    Manufacturer
    ACRO Biomedical Co., Ltd.
    Date Cleared
    2024-10-18

    (382 days)

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

    ACRO Biomedical Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ABCcolla® Collagen ADM Scaffold is intended to be used for management of wounds. including venous ulcers, pressure ulcers, chronic vascular ulcers, diabetic ulcers, tunneled undermined wounds (donor site/ grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, and skin tears), first and second-degree burns, draining wounds.
    Device Description
    ABCcolla® Collagen ADM Scaffold is a decellularized porcine collagen biomaterial from porcine dermis. When applied on a wound, this product helps absorb wound exudates and maintain a moist wound environment.
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    K Number
    K212156
    Device Name
    ABCcolla Bone Matrix
    Manufacturer
    ACRO Biomedical Co., Ltd.
    Date Cleared
    2021-10-08

    (88 days)

    Product Code
    MQV
    Regulation Number
    888.3045
    Why did this record match?
    Applicant Name (Manufacturer) :

    ACRO Biomedical Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ABCcolla® Bone Matrix is intended to fill bony voids or gaps of skeletal system (i.e., extremities and pelvis). These osseous defects are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of bone structure. ABCcolla® Bone Matrix provides resorbs and is replaced by bone during the healing process.
    Device Description
    ABCcolla® Bone Matrix is a bone mineral matrix of porcine origin. ABCcolla® Bone Matrx is physically and chemically comparable to the mineralized matrix of human bone.
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    K Number
    K171629
    Device Name
    ABCcolla Bone Graft
    Manufacturer
    ACRO Biomedical Co., Ltd.
    Date Cleared
    2018-02-01

    (244 days)

    Product Code
    MQV, MOV
    Regulation Number
    888.3045
    Why did this record match?
    Applicant Name (Manufacturer) :

    ACRO Biomedical Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ABCcolla® Bone Graft is an implant intended to fill bony voids or gaps of the skeletal system (i.e., extremities and pelvis). These osseous defects are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. ABCcolla® Bone Graft resorbs and is replaced with bone during the healing process.
    Device Description
    ABCcolla® Bone Graft is a bone mineral matrix of porcine origin. ABCcolla® Bone Graft is physically and chemically comparable to the mineralized matrix of human bone.
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