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

    PIONEER SPINAL PROCESS FUSION PLATE

    K Number: K110367 · Decision Mar 23, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    321
    Registration Numbers
    321
    Same Product Code
    429
    Applicant Total
    26
    Review Days
    43

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    Basic Information

    Device Name
    PIONEER SPINAL PROCESS FUSION PLATE
    K Number
    K110367
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3050
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Pioneer Surgical Technology, Inc.
    Date Received
    February 8, 2011
    Decision Date
    March 23, 2011
    Product Code
    KWP
    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
    KWP Appliance, Fixation, Spinal Interlaminal

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