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

    SYNTHES AIR PEN DRIVE (APD) SYSTEM

    K Number: K093361 · Decision Apr 14, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    46
    Registration Numbers
    46
    Same Product Code
    26
    Applicant Total
    402
    Review Days
    168

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    Basic Information

    Device Name
    SYNTHES AIR PEN DRIVE (APD) SYSTEM
    K Number
    K093361
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4370
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Synthes (Usa)
    Date Received
    October 28, 2009
    Decision Date
    April 14, 2010
    Product Code
    HBB
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    HBB Motor, Drill, Pneumatic

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