BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Prosthesis, Spinous Process Spacer/Plate

    PMA: P110008 · Decision Oct 17, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23

    Basic Information

    Device Name
    Prosthesis, Spinous Process Spacer/Plate
    Trade Name
    COFLEX® INTERLAMINAR TECHNOLOGY
    PMA Number
    P110008
    Device Class
    FDA Class 3
    Product Code
    NQO
    Generic Name
    Prosthesis, spinous process spacer/plate
    Medical Specialty
    Unknown
    Advisory Committee
    Orthopedic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    October 17, 2012
    Date Received
    March 3, 2011
    Expedited Review
    N
    Docket Number
    12M-1085

    Advisory Committee Statement

    APPROVAL FOR THE COFLEX INTERLAMINAR TECHNOLOGY. THIS DEVICE IS INDICATED FOR USE IN ONE- OR TWO-LEVEL LUMBAR STENOSIS FROM L1- L5 IN SKELETALLY MATURE PATIENTS WITH AT LEAST MODERATE IMPAIRMENT IN FUNCTION, WHO EXPERIENCE RELIEF IN FLEXION FROM THEIR SYMPTOMS OF LEG/BUTTOCKS/ GROIN PAIN, WITH OR WITHOUT BACK PAIN, AND WHO HAVE UNDERGONE AT LEAST 6 MONTH OF NON-OPERATIVE TREATMENT. THE COFLEX IS INTENDED TO BE IMPLANTED MIDLINE BETWEEN ADJACENT LAMINA OF 1 OR 2 CONTIGUOUS LUMBAR MOTION SEGMENTS. INTERLAMINAR STABILIZATION IS PERFORMED AFTER DECOMPRESSION OF STENOSIS AT THE AFFECTED LEVEL(S).

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NQO Prosthesis, Spinous Process Spacer/Plate