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

    Bolo Button System

    K Number: K242091 · Decision Dec 23, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    272
    Registration Numbers
    272
    Same Product Code
    92
    Applicant Total
    2
    Review Days
    159

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    Basic Information

    Device Name
    Bolo Button System
    K Number
    K242091
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Fusion Orthopedics
    Date Received
    July 17, 2024
    Decision Date
    December 23, 2024
    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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