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

    CTC TCAT(R)-TPLAN(R) SURGICAL SYSTEM

    K Number: K140585 · Decision Aug 18, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    3
    Applicant Total
    2
    Review Days
    164

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    Basic Information

    Device Name
    CTC TCAT(R)-TPLAN(R) SURGICAL SYSTEM
    K Number
    K140585
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4560
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Curexo Technology Corporation
    Date Received
    March 7, 2014
    Decision Date
    August 18, 2014
    Product Code
    OJP
    Advisory Committee
    Neurology
    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
    OJP Orthopedic Computer Controlled Surgical System

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