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

    VERSATRAC (TM) LUMBAR RETRACTOR SYSTEM

    K Number: K964402 · Decision Jan 23, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    80
    Registration Numbers
    80
    Same Product Code
    42
    Applicant Total
    8
    Review Days
    80

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    Basic Information

    Device Name
    VERSATRAC (TM) LUMBAR RETRACTOR SYSTEM
    K Number
    K964402
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4800
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    V. Mueller Neuro/Spine
    Date Received
    November 4, 1996
    Decision Date
    January 23, 1997
    Product Code
    GZT
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GZT Retractor, Self-Retaining, For Neurosurgery

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