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

    Tandry CMF Plate System

    K Number: K220360 · Decision Nov 10, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    106
    Registration Numbers
    106
    Same Product Code
    291
    Applicant Total
    8
    Review Days
    275

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    Basic Information

    Device Name
    Tandry CMF Plate System
    K Number
    K220360
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.4760
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Microware Precision Co., Ltd.
    Date Received
    February 8, 2022
    Decision Date
    November 10, 2022
    Product Code
    JEY
    Advisory Committee
    Dental
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JEY Plate, 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
    K220359 Tandry Compression Screw 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