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510(k) Data Aggregation

    K Number
    K220759
    Device Name
    Armis VeriCyn Wound Wash
    Manufacturer
    Armis Biopharma, Inc.
    Date Cleared
    2023-05-25

    (436 days)

    Product Code
    FQH, FRO
    Regulation Number
    880.5475
    Why did this record match?
    Applicant Name (Manufacturer) :

    Armis Biopharma, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Armis VeriCyn® Wound Wash is to be used with a lavage system to create mechanical movement at the wound surface by delivery of a solution and is indicated for use in cleansing and removal of foreign material including microorganisms and debris from wounds (such as stage I-IV pressure ulcers, diabetic foot ulcers, post surgical wounds, first degree and partial thickness burns, grafted and donor sites).
    Device Description
    The ARMIS VeriCyn® Wound Wash is an aqueous solution for irrigation and debridement of wounds. The solution is a clear, colorless, no-odor aqueous solution that is used to remove debris, including microorganisms from wounds though the use of a lavage system. ARMIS VeriCyn® Wound Wash contains: Hydrogen Peroxide, Acetic Acid, Disodium EDTA and Purified water. VeriCyn® Wound Wash has been tested for compliance with ISO 10993.
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    K Number
    K202777
    Device Name
    VeriFixx™ Small Bone Implant
    Manufacturer
    Armis Biopharma, Inc.
    Date Cleared
    2020-11-17

    (56 days)

    Product Code
    HTY
    Regulation Number
    888.3040
    Why did this record match?
    Applicant Name (Manufacturer) :

    Armis Biopharma, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VeriFixx™ Small Bone Implant is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe.
    Device Description
    The VeriFixx™ SBI is single use, gamma sterilized device that is surgically implanted into the intramedullary canal of the bones in the toe to create a fusion and provides stability and maintain the alignment of bone during the healing process. The device is a solid, non-threaded implant that has a superior surface protrusion known as the dorsal fin, which is intended to maintain alignment of the joint during the healing process.
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