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

    Response 5.5/6.0 Spine System

    K Number: K150600 · Decision May 22, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    413
    Registration Numbers
    413
    Same Product Code
    873
    Applicant Total
    2
    Review Days
    73

    Basic Information

    Device Name
    Response 5.5/6.0 Spine System
    K Number
    K150600
    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
    March 10, 2015
    Decision Date
    May 22, 2015
    Product Code
    NKB
    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
    NKB Thoracolumbosacral Pedicle Screw System

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    Other Clearances by ORTHOPEDIATRICS CORP.

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