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

    DSM Biomedical Calcium Phosphate Cement

    K Number: K173362 · Decision Apr 3, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    229
    Registration Numbers
    229
    Same Product Code
    491
    Applicant Total
    7
    Review Days
    159

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    Basic Information

    Device Name
    DSM Biomedical Calcium Phosphate Cement
    K Number
    K173362
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3045
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Kensey Nash Corporation Dba Dsm Biomedical
    Date Received
    October 26, 2017
    Decision Date
    April 3, 2018
    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 Kensey Nash Corporation Dba Dsm Biomedical

    K Number Device Name
    K173572 DSM Biomedical Calcium Phosphate Cement with Microspheres
    K170245 DSM Biomedical Dental Bone Graft
    K160474 DSM Biomedical Porcine Pericardium Dental Membrane
    K141738 MEDEOR MATRIX WOUND DRESSING
    K133169 MESO TENDON MATRIX
    K132025 MESO BILAYER SURGICAL MESH