BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Intervertebral Fusion Device With Bone Graft, Lumbar

    PMA: P970015 · Supplement: S017 · Decision Dec 13, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    422
    Registration Numbers
    422

    Basic Information

    Device Name
    Intervertebral Fusion Device With Bone Graft, Lumbar
    Trade Name
    INTER FIX RP THREADED FUSION DEVICE-REDUCED PROFILE
    PMA Number
    P970015
    Supplement Number
    S017
    Device Class
    FDA Class 2
    Product Code
    MAX
    Generic Name
    Intervertebral fusion device with bone graft, lumbar
    Regulation Number
    888.3080
    Medical Specialty
    Orthopedic
    Advisory Committee
    Orthopedic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    December 13, 2000
    Date Received
    September 28, 2000
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE INTERFIX(TM) RP THREADED FUSION DEVICE TO BE ALSO KNOWN AS THE INTERFIX(TM) RP THREADED FUSION DEVICE - REDUCED PROFILE. THE DEVICE WILL NOW BE MARKETED UNDER BOTH TRADE NAMES AND WILL REMAIN INDICATED FOR USE WITH AUTOGENOUS BONE BRAFT IN PATIENTS WITH DEGENERATIVE DISC DISEASE (DDD) AT ONE LEVEL FROM L2-S1. THESE DDD PATIENTS MAY ALSO HAVE UP TO GRADE I SPONDYLOLISTHESIS OR RETROLISTHESIS AT THE INVOLVED LEVEL. THE DEVICE IS TO BE IMPLANTED VIA AN OPEN ANTERIOR APPROACH. DDD IS DEFINED AS DISCOGENIC BACK PAIN WITH DEGENERATION OF THE DISC CONFIRMED BY HISTORY AND RADIOGRAPHIC STUDIES. THESE PATIENTS SHOULD BE SKELETALLY MATURE AND HAVE HAD SIX MONTHS OF NON-OPERATIVE TREATMENT.

    Classifications

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

    Product Code Device Name
    MAX Intervertebral Fusion Device With Bone Graft, Lumbar