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

    Paonan Armstrong Posterior Spinal Fixation System

    K Number: K161225 · Decision Aug 11, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    407
    Registration Numbers
    407
    Same Product Code
    900
    Applicant Total
    6
    Review Days
    452

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    Basic Information

    Device Name
    Paonan Armstrong Posterior Spinal Fixation System
    K Number
    K161225
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3070
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Paonan Biotech Co., Ltd.
    Date Received
    May 16, 2016
    Decision Date
    August 11, 2017
    Product Code
    NKB
    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
    NKB Thoracolumbosacral Pedicle Screw System

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