BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    NanoBone SBX PUTTY, NanoBone QD

    K Number: K190110 · Decision Apr 23, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    229
    Registration Numbers
    229
    Same Product Code
    491
    Applicant Total
    3
    Review Days
    90

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    Basic Information

    Device Name
    NanoBone SBX PUTTY, NanoBone QD
    K Number
    K190110
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3045
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Artoss GmbH
    Date Received
    January 23, 2019
    Decision Date
    April 23, 2019
    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 Artoss GmbH

    K Number Device Name
    K161351 NanoBone SBX Putty
    K141189 NANOBONE / GRANULATE