BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    LTJ Screws and Washer

    K Number: K210268 · Decision Feb 26, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    659
    Registration Numbers
    659
    Same Product Code
    1058
    Applicant Total
    2
    Review Days
    25

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    Basic Information

    Device Name
    LTJ Screws and Washer
    K Number
    K210268
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3040
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Azurmeds, Inc.
    Date Received
    February 1, 2021
    Decision Date
    February 26, 2021
    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 Azurmeds, Inc.

    K Number Device Name
    K200987 LTJ Screws and Washer