BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇳 India

    Pitkar External Fixation System

    K Number: K190486 · Decision Oct 16, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    249
    Registration Numbers
    249
    Same Product Code
    403
    Applicant Total
    5
    Review Days
    230

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    Basic Information

    Device Name
    Pitkar External Fixation System
    K Number
    K190486
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    S.H.Pitkar Orthotools Pvt. , Ltd.
    Date Received
    February 28, 2019
    Decision Date
    October 16, 2019
    Product Code
    KTT
    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
    KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

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    Other Clearances by S.H.Pitkar Orthotools Pvt. , Ltd.

    K Number Device Name
    K240233 Pitkar Spinal Pedicle Screw System
    K200728 Pitkar DeftFix System
    K200518 Pitkar External Fixation System - Rail Mechanism
    K192619 Pitkar Locked Plating System