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

    CERAMENT IBONE VOID FILLER HIGH CONTRAST, MODEL A 0210-12

    K Number: K090871 · Decision Sep 4, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    229
    Registration Numbers
    229
    Same Product Code
    491
    Applicant Total
    7
    Review Days
    158

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    Basic Information

    Device Name
    CERAMENT IBONE VOID FILLER HIGH CONTRAST, MODEL A 0210-12
    K Number
    K090871
    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
    March 30, 2009
    Decision Date
    September 4, 2009
    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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    DEN210044 CERAMENT G
    K201535 Cerament Bone Void Filler
    K073316 CERAMENT BONE VOID FILLER, MODEL A0210
    K051951 CERAMENT BONE VOID FILLER