BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    TANGORS POLYAXIAL SYSTEM

    K Number: K052385 · Decision Dec 27, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    407
    Registration Numbers
    407
    Same Product Code
    900
    Applicant Total
    24
    Review Days
    119

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    Basic Information

    Device Name
    TANGORS POLYAXIAL SYSTEM
    K Number
    K052385
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3070
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ulrich GmbH & Co. KG
    Date Received
    August 30, 2005
    Decision Date
    December 27, 2005
    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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