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510(k) Data Aggregation

    K Number
    K212579
    Device Name
    FortiShield (Biosynthetic Wound Matrix)
    Manufacturer
    Date Cleared
    2023-05-02

    (624 days)

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

    Organogenesis Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    FortiShield is intended for use as a temporary wound covering, and to provide a moist wound healing environment on cleanly debrided wounds after hemostasis has been established. FortiShield is indicated for: partial thickness wounds, pressure sores, venous ulcers, diabetic ulcers, chronic vascular ulcers, surgical wounds (donor sites/grafts, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, partial thickness burns, and skin tears) and draining wounds.
    Device Description
    FortiShield is a sterile, translucent biosynthetic wound matrix made from a knitted tri-filament nylon fabric that is mechanically bonded to a semi-permeable silicone membrane. Denatured porcine dermal collagen is bonded to the nylon/silicone bi-layer membrane to provide a dressing that is designed to adhere to the application site, provide a barrier to the external environment, and allow for excess exudate drainage. FortiShield is not made with natural rubber latex. FortiShield is non-pyrogenic.
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    K Number
    K220317
    Device Name
    PuraPly Micronized Wound Matrix (PuraPly MZ)
    Manufacturer
    Date Cleared
    2022-07-01

    (148 days)

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

    Organogenesis Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    PuraPly® Micronized Wound Matrix (PuraPly® MZ) is intended for the management of wounds that include: - · Partial and full-thickness wounds - Pressure ulcers - Venous ulcers - · Diabetic ulcers - Chronic vascular ulcers - · Tunneled/undermined wounds - Surgical wounds (e.g., donor sites/grafts, post-Mohs' surgery, Podiatric wound, and wound dehiscence). - · Trauma wounds (e.g., abrasions, lacerations, and skin tears) - Partial thickness burns - Draining wounds The device is intended for single patient use only.
    Device Description
    PuraPly® Micronized Wound Matrix (PuraPly® MZ) consists of micronized porcine collagen intended for the management of wounds. PuraPly® Micronized Wound Matrix is supplied as a dry powder of particle size of ≤ 1000μm. The device is sterile and packaged in a vial sealed in a single pouch.
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