BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇸🇪 Sweden

    Cerament Bone Void Filler

    K Number: K240459 · Decision Mar 5, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    229
    Registration Numbers
    229
    Same Product Code
    491
    Applicant Total
    7
    Review Days
    18

    Basic Information

    Device Name
    Cerament Bone Void Filler
    K Number
    K240459
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3045
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bonesupport AB
    Date Received
    February 16, 2024
    Decision Date
    March 5, 2024
    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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    Other Clearances by Bonesupport AB

    K Number Device Name
    K234008 CERAMENT G
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    K201535 Cerament Bone Void Filler
    K090871 CERAMENT IBONE VOID FILLER HIGH CONTRAST, MODEL A 0210-12
    K073316 CERAMENT BONE VOID FILLER, MODEL A0210
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