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

    ARS SCREW; SLANT SCREW

    K Number: K130954 · Decision May 31, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    653
    Registration Numbers
    653
    Same Product Code
    1040
    Applicant Total
    2
    Review Days
    56

    Basic Information

    Device Name
    ARS SCREW; SLANT SCREW
    K Number
    K130954
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3040
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    ADVANCED INTERVENTIONAL TECHNOLOGY, LLC
    Date Received
    April 5, 2013
    Decision Date
    May 31, 2013
    Product Code
    HWC
    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
    HWC Screw, Fixation, Bone

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