BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇰🇷 South Korea

    RONAVIS – FX (FX-001)

    K Number: K250315 · Decision Aug 1, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    283
    Registration Numbers
    283
    Same Product Code
    203
    Applicant Total
    1
    Review Days
    178

    Basic Information

    Device Name
    RONAVIS – FX (FX-001)
    K Number
    K250315
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3040
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    AIRS, Inc.
    Date Received
    February 4, 2025
    Decision Date
    August 1, 2025
    Product Code
    HTY
    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
    HTY Pin, Fixation, Smooth

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