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

    BIODRIVE MICRO SCREW SYSTEM

    K Number: K092670 · Decision Nov 19, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    519
    Registration Numbers
    519
    Same Product Code
    1313
    Applicant Total
    1
    Review Days
    80

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    Basic Information

    Device Name
    BIODRIVE MICRO SCREW SYSTEM
    K Number
    K092670
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ebi,Llc D/B/A Biomet Trauma
    Date Received
    August 31, 2009
    Decision Date
    November 19, 2009
    Product Code
    HRS
    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
    HRS Plate, Fixation, Bone

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