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

    Tandry Locking Plate System

    K Number: K171904 · Decision Sep 18, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    519
    Registration Numbers
    519
    Same Product Code
    1313
    Applicant Total
    8
    Review Days
    449

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    Basic Information

    Device Name
    Tandry Locking Plate System
    K Number
    K171904
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Microware Precision Co., Ltd.
    Date Received
    June 26, 2017
    Decision Date
    September 18, 2018
    Product Code
    HRS
    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
    HRS Plate, Fixation, Bone

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    Other Clearances by Microware Precision Co., Ltd.

    K Number Device Name
    K242814 Tandry Q-Locking Plate System
    K230690 Tandry Locking Plate System
    K220360 Tandry CMF Plate System
    K220359 Tandry Compression Screw System
    K182929 BIO-RAY A-1 Anchor Screw System
    K111008 MICROWARE BONE PLATES AND BONE SCREW
    K072562 MICROWARE BONE PLATES AND BONE SCREWS