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

    BIOMET MICROFIXATION STERNAL CLOSURE SYSTEM

    K Number: K111908 · Decision Nov 29, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    659
    Registration Numbers
    659
    Same Product Code
    1058
    Applicant Total
    5
    Review Days
    147

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    Basic Information

    Device Name
    BIOMET MICROFIXATION STERNAL CLOSURE SYSTEM
    K Number
    K111908
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3040
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biomet Microfixation, Inc.
    Date Received
    July 5, 2011
    Decision Date
    November 29, 2011
    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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