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510(k) Data Aggregation

    K Number
    K172937
    Device Name
    Colorado Therapeutics Xenograft Implant
    Date Cleared
    2017-10-25

    (29 days)

    Product Code
    Regulation Number
    878.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    Colorado Therapeutics LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Colorado Therapeutics Xenograft Implant is intended to be used for implantation to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes. It is supplied sterile. It is intended for one-time use.
    Device Description
    Colorado Therapeutics Xenograft Implant is a sterile implant consisting of porcine pericardium. It is glutaraldehyde cross-linked, sterilized by ethylene oxide (EO) and packaged dry with no rinsing or rehydration required. The Colorado Therapeutics proprietary process produces a uniquely thin, dry, and durable xenograft implant, which makes possible an advantageous xenograft product. The only change in this Special 510(k) Notification is the addition of two sizes: 02x03cm and 04x04cm. These sizes are both outside the 36cm² and 90cm² sizes in K160181. This change represents a notification to the original device, K160181, and changes in dimensions are considered appropriate for review as a Special 510(k).
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    K Number
    K160181
    Device Name
    COLORADO THERAPEUTICS XENOGRAFT IMPLANT
    Date Cleared
    2016-10-20

    (267 days)

    Product Code
    Regulation Number
    878.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    Colorado Therapeutics LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Colorado Therapeutics Xenograft Implant is intended to be used for implantation to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes. It is supplied sterile. It is intended for one-time use.
    Device Description
    Colorado Therapeutics Xenograft Implant is a sterile implant consisting of porcine pericardium. It is glutaraldehyde cross-linked, sterilized by ethylene oxide (EO) and packaged dry with no rehydration required. The Colorado Therapeutics proprietary process produces a uniquely thin and dry xenograft implant that provides the suitable strength, and biocompatibility for a soft tissue repair implant.
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