BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇰🇷 South Korea

    ANAX™ 5.5 Spinal System

    K Number: K162189 · Decision Aug 30, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    338
    Registration Numbers
    338
    Same Product Code
    308
    Applicant Total
    8
    Review Days
    26

    Basic Information

    Device Name
    ANAX™ 5.5 Spinal System
    K Number
    K162189
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3070
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    U&I Corporation
    Date Received
    August 4, 2016
    Decision Date
    August 30, 2016
    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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