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

    CENTRA-LINE GRAPPLE, VARIFIX SYSTEM

    K Number: K954770 · Decision Jan 25, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    321
    Registration Numbers
    321
    Same Product Code
    429
    Applicant Total
    16
    Review Days
    100

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    Basic Information

    Device Name
    CENTRA-LINE GRAPPLE, VARIFIX SYSTEM
    K Number
    K954770
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3050
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Advanced Spine Fixation Systems, Inc.
    Date Received
    October 17, 1995
    Decision Date
    January 25, 1996
    Product Code
    KWP
    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
    KWP Appliance, Fixation, Spinal Interlaminal

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