BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇼 Taiwan

    AAXTER A3 POSTERIOR SPINAL SYSTEM

    K Number: K101374 · Decision Mar 16, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    326
    Registration Numbers
    326
    Same Product Code
    308
    Applicant Total
    1
    Review Days
    303

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    Basic Information

    Device Name
    AAXTER A3 POSTERIOR SPINAL SYSTEM
    K Number
    K101374
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3070
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Aaxter Co., Ltd.
    Date Received
    May 17, 2010
    Decision Date
    March 16, 2011
    Product Code
    MNH
    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
    MNH Orthosis, Spondylolisthesis Spinal Fixation

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