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

    RESPONSE™ Rib and Pelvic System

    K Number: K233105 · Decision Jan 20, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    1
    Applicant Total
    40
    Review Days
    115

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    Basic Information

    Device Name
    RESPONSE™ Rib and Pelvic System
    K Number
    K233105
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3070
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    OrthoPediatrics Corp.
    Date Received
    September 27, 2023
    Decision Date
    January 20, 2024
    Product Code
    MDI
    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
    MDI Prosthesis, Rib Replacement

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