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

    SINTEA PLUSTEK PLS MULTI-AXIAL SCREWS

    K Number: K112611 · Decision Apr 25, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    342
    Registration Numbers
    342
    Same Product Code
    302
    Applicant Total
    2
    Review Days
    231

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    Basic Information

    Device Name
    SINTEA PLUSTEK PLS MULTI-AXIAL SCREWS
    K Number
    K112611
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3070
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sintea Plastek, LLC
    Date Received
    September 7, 2011
    Decision Date
    April 25, 2012
    Product Code
    MNI
    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
    MNI Orthosis, Spinal Pedicle Fixation

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    Other Clearances by Sintea Plastek, LLC

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