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510(k) Data Aggregation

    K Number
    K223563
    Device Name
    OsteoCNX
    Date Cleared
    2023-01-25

    (57 days)

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

    Converg Engineering

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    OsteoCNX Bone Graft Substitute is intended for use as a bone void filler to fill voids or gaps of the skeletal system not intrinsic to the stability of the bony structure (extremities, pelvis, posterior lateral spine). OsteoCNX Bone Graft Substitute is also indicated for use in the treatment of surgically created osseous defects created from traumatic injury to the bone. OsteoCNX Bone Graft Substitute must be wetted with bone marrow aspirate or, when used in the posterolateral spine, autologous bone must also be added (50/50 ratio by volume). Following placement in the bony void or gap (defect), OsteoCNX Bone Graft Substitutes are resorbed with bone during the healing process
    Device Description
    Not Found
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