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

    SportLinc Syndesmosis Device

    K Number: K252081 · Decision Mar 27, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    272
    Registration Numbers
    272
    Same Product Code
    92
    Applicant Total
    2
    Review Days
    268

    Basic Information

    Device Name
    SportLinc Syndesmosis Device
    K Number
    K252081
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Lincotek Medical
    Date Received
    July 2, 2025
    Decision Date
    March 27, 2026
    Product Code
    HTN
    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
    HTN Washer, Bolt Nut

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