BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    PRO-DENSE LoVisc Bone Graft Substitute

    K Number: K200507 · Decision Oct 21, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    234
    Registration Numbers
    234
    Same Product Code
    483
    Applicant Total
    35
    Review Days
    233

    Basic Information

    Device Name
    PRO-DENSE LoVisc Bone Graft Substitute
    K Number
    K200507
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3045
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Wright Medical Technology, Inc.
    Date Received
    March 2, 2020
    Decision Date
    October 21, 2020
    Product Code
    MQV
    Advisory Committee
    Orthopedic
    Review Advisory Committee
    OR
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MQV Filler, Bone Void, Calcium Compound

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