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

    STABILIZ FIXATION SYSTEM

    K Number: K120651 · Decision Nov 27, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    519
    Registration Numbers
    519
    Same Product Code
    1313
    Applicant Total
    2
    Review Days
    270

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    Basic Information

    Device Name
    STABILIZ FIXATION SYSTEM
    K Number
    K120651
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Stabiliz Orthopaedics, LLC
    Date Received
    March 2, 2012
    Decision Date
    November 27, 2012
    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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    Other Clearances by Stabiliz Orthopaedics, LLC

    K Number Device Name
    K130731 STABILIZ FIXATION SYSTEM - SPL LOCKING SCREW