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

    LAMINOPLASY PLATING SYSTEM

    K Number: K103284 · Decision Dec 2, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    67
    Registration Numbers
    67
    Same Product Code
    29
    Applicant Total
    22
    Review Days
    27

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    Basic Information

    Device Name
    LAMINOPLASY PLATING SYSTEM
    K Number
    K103284
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3050
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Aesculap Implant Systems, Inc.
    Date Received
    November 5, 2010
    Decision Date
    December 2, 2010
    Product Code
    NQW
    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
    NQW Orthosis, Spine, Plate, Laminoplasty, Metal

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