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

    MILAGRO INTERFERENCE SCREWS

    K Number: K122869 · Decision Dec 13, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    147
    Registration Numbers
    147
    Same Product Code
    219
    Applicant Total
    58
    Review Days
    85

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    Basic Information

    Device Name
    MILAGRO INTERFERENCE SCREWS
    K Number
    K122869
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Depuy Mitek, A Johnson & Johnson Company
    Date Received
    September 19, 2012
    Decision Date
    December 13, 2012
    Product Code
    MAI
    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
    MAI Fastener, Fixation, Biodegradable, Soft Tissue

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    Other Clearances by Depuy Mitek, A Johnson & Johnson Company

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    K140896 VAPR ARCTIC SUCTION ELECTRODE
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    K132241 GRYPHON BR ANCHOR W/ PROKNOT TECHNOLOGY, GRYPHON BR ANCHOR W/ PROKNOT TECHNOLOGY - HIP, GRYPHON PEEK ANCHOR W/ PROKNOT T
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    K131974 HEALIX ADVANCE KNOTLESS BR ANCHOR (6.5MM)
    K131191 4MM & 5MM FULL RADIUS BLADE PLUS, 4MM & 5MM BARREL BUR PLUS/4MM BARREL TORNADO BUR PLUS, 4MM & 5MM AGGRESSIVE BLADE PLUS
    K130912 OMNICUT RESECTION BLADE
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