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

    WELLGRAFT PE II

    K Number: K072170 · Decision Apr 4, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    234
    Registration Numbers
    234
    Same Product Code
    483
    Applicant Total
    2
    Review Days
    242

    Basic Information

    Device Name
    WELLGRAFT PE II
    K Number
    K072170
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3045
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    GWOWEI TECHNOLOGY CO., LTD.
    Date Received
    August 6, 2007
    Decision Date
    April 4, 2008
    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 GWOWEI TECHNOLOGY CO., LTD.

    K Number Device Name
    K072444 WELLGRAFT PE I