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

    INTERBRIDGE INTERSPINOUS POSTERIOR FIXATION SYSTEM

    K Number: K133363 · Decision Mar 7, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    75
    Registration Numbers
    75
    Same Product Code
    47
    Applicant Total
    10
    Review Days
    126

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    Basic Information

    Device Name
    INTERBRIDGE INTERSPINOUS POSTERIOR FIXATION SYSTEM
    K Number
    K133363
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3050
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ldr Spine USA, Inc.
    Date Received
    November 1, 2013
    Decision Date
    March 7, 2014
    Product Code
    PEK
    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
    PEK Spinous Process Plate

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