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

    Moldable Bone Void Filler and Moldable Bone Void Filler + CCC

    K Number: K241555 · Decision Feb 21, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    229
    Registration Numbers
    229
    Same Product Code
    491
    Applicant Total
    7
    Review Days
    266

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    Basic Information

    Device Name
    Moldable Bone Void Filler and Moldable Bone Void Filler + CCC
    K Number
    K241555
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3045
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Rti Surgical, Inc.
    Date Received
    May 31, 2024
    Decision Date
    February 21, 2025
    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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