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510(k) Data Aggregation

    K Number
    K231708
    Device Name
    Axoguard HA+ Nerve Protector (AGHA12); Axoguard HA+ Nerve Protector (AGHA22); Axoguard HA+ Nerve Protector (AGHA24); Axoguard HA+ Nerve Protector (AGHA36); Axoguard HA+ Nerve Protector (AGHA48)
    Manufacturer
    AxoGen Corporation
    Date Cleared
    2023-10-12

    (122 days)

    Product Code
    JXI
    Regulation Number
    882.5275
    Why did this record match?
    Applicant Name (Manufacturer) :

    AxoGen Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Axoguard HA+ Nerve Protector is indicated for the management and peripheral nerve injuries where there is no gap, or following closure of the gap.
    Device Description
    Axoguard HA+ Nerve Protector is a surgical implant that provides non-constricting protection for peripheral nerve injuries. Axoguard HA+ Nerve Protector is designed to aid in coaptation and protection of peripheral nerve injuries by serving as an interface between the nerve and the surrounding tissue and also providing tension relief when used as a coaptation aid. Axoguard HA+ Nerve Protector is comprised of an extracellular matrix (ECM) and is fully remodeled during the healing process. When hydrated, Axoguard HA+ Nerve Protector is easy to handle, soft, pliable, nonfriable, and porous. The lubricant coating on Axoguard HA+ Nerve Protector is composed of sodium hyaluronate and sodium alginate. When hydrated, the lubricant coating reduces friction between the nerve and the surrounding tissue. Axoguard HA+ Nerve Protector is flexible to accommodate movement of the joint and has sufficient mechanical strength to hold sutures. Axoguard HA+ Nerve Protector is provided sterile, for single use only, and in a variety of sizes to meet the surgeon's needs.
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    K Number
    K223640
    Device Name
    Axoguard HA+ Nerve Protector (AGHA12); Axoguard HA+ Nerve Protector (AGHA22); Axoguard HA+ Nerve Protector (AGHA24); Axoguard HA+ Nerve Protector (AGHA36); Axoguard HA+ Nerve Protector (AGHA48)
    Manufacturer
    AxoGen Corporation
    Date Cleared
    2023-04-07

    (123 days)

    Product Code
    JXI, AXO
    Regulation Number
    882.5275
    Why did this record match?
    Applicant Name (Manufacturer) :

    AxoGen Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Axoguard HA+ Nerve Protector is indicated for the management of peripheral nerve injuries where is no gap.
    Device Description
    The Axoguard HA+ Nerve Protector is a surgical implant that provides non-constricting protection for peripheral nerves. Axoguard HA+ Nerve Protector is designed to be an interface between the nerve and the surrounding tissue. Axoguard HA+ Nerve Protector is comprised of an extracellular matrix (ECM) and is fully remodeled during the healing process. The lubricant coating on Axoguard HA+ Nerve Protector is composed of sodium hyaluronate and sodium alginate. When hydrated, the lubricant coating reduces friction between the nerve and the surrounding tissue. Axoguard HA+ Nerve Protector is flexible to accommodate movement of the joint and associated tendons and has sufficient mechanical strength to hold sutures. Axoguard HA+ Nerve Protector is provided sterile, for single use only, and in a variety of sizes to meet surgeons' needs.
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    K Number
    K163446
    Device Name
    AxoGen Nerve Cap
    Manufacturer
    AxoGen Corporation
    Date Cleared
    2017-08-08

    (243 days)

    Product Code
    JXI
    Regulation Number
    882.5275
    Why did this record match?
    Applicant Name (Manufacturer) :

    AxoGen Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AxoGen Nerve Cap is indicated to protect a peripheral nerve end and to separate the nerve from surrounding environment to reduce the development of symptomatic or painful neuroma.
    Device Description
    The AxoGen Nerve Cap is a surgical implant that is a tubular device with one open end, one sealed end (cap) and internal channels designed to provide protection for a peripheral nerve end or stump where repair is unattainable or not desired. The device prevents dislocation of the nerve end by pulling the nerve into the tube, suturing the nerve within the cap, and securing the tab to the surrounding tissue. AxoGen Nerve Cap is an extracellular matrix (ECM) and is fully remodeled during the healing process. The device is manufactured from processed porcine small intestinal submucosa (SIS) which is vacuum pressed prior to packaging. After hydration, the device is easy to handle, soft, pliable, non-friable and porous. AxoGen Nerve Cap is flexible to accommodate movement of the joints and surrounding soft tissues and has sufficient mechanical strength to hold appropriately sized nonabsorbable suture. It is supplied in nominal tube diameters ranging from 1.5mm up to 8mm, and a length of 13mm-38mm. AxoGen Nerve Cap is provided sterile, for single use only, and in a variety of sizes to meet clinical needs.
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