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

    CERAMENT G

    K Number: K234008 · Decision Mar 13, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    1
    Applicant Total
    7
    Review Days
    85

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    Basic Information

    Device Name
    CERAMENT G
    K Number
    K234008
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3046
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bonesupport AB
    Date Received
    December 19, 2023
    Decision Date
    March 13, 2024
    Product Code
    QRR
    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
    QRR Filler, Bone Void, Calcium Compound Containing Single Approved Aminoglycoside

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (QRR), ordered by most recent decision date.

    CERAMENT G

    FDA 510(k)
    FDA Class 2 ·Orthopedic
    View all

    Other Clearances by Bonesupport AB

    K Number Device Name
    K240459 Cerament Bone Void Filler
    DEN210044 CERAMENT G
    K201535 Cerament Bone Void Filler
    K090871 CERAMENT IBONE VOID FILLER HIGH CONTRAST, MODEL A 0210-12
    K073316 CERAMENT BONE VOID FILLER, MODEL A0210
    K051951 CERAMENT BONE VOID FILLER