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

    Tandry Compression Screw System

    K Number: K220359 · Decision Sep 20, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    659
    Registration Numbers
    659
    Same Product Code
    1058
    Applicant Total
    8
    Review Days
    224

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    Basic Information

    Device Name
    Tandry Compression Screw System
    K Number
    K220359
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3040
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Microware Precision Co., Ltd.
    Date Received
    February 8, 2022
    Decision Date
    September 20, 2022
    Product Code
    HWC
    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
    HWC Screw, Fixation, Bone

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    Other Clearances by Microware Precision Co., Ltd.

    K Number Device Name
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    K220360 Tandry CMF Plate System
    K182929 BIO-RAY A-1 Anchor Screw System
    K171904 Tandry Locking Plate System
    K111008 MICROWARE BONE PLATES AND BONE SCREW
    K072562 MICROWARE BONE PLATES AND BONE SCREWS