BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Intervertebral Fusion Device With Bone Graft, Lumbar

    PMA: P970015 · Supplement: S019 · Decision Jul 19, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    422
    Registration Numbers
    422

    Basic Information

    Device Name
    Intervertebral Fusion Device With Bone Graft, Lumbar
    Trade Name
    DUAL INTERFIX-RP(TM) THREADED FUSION DEVICE
    PMA Number
    P970015
    Supplement Number
    S019
    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
    July 19, 2001
    Date Received
    April 9, 2001
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR USE OF DUAL INTERFIX-RP(TM) THREADED FURSION DEVICES (INSTEAD OF THE ALREADY APPROVED USE OF A SINGLE INTERFIX-RP(TM) THREADED FUSION DEVICE USED IN CONJUNCTION WITH AN INTERFIX(TM) THREADED FUSION DEVICE) THE UNMODIFIED DEVICE WILL CONTINUE TO BE MARKETED UNDER THE TRADE NAME INTERFIX-RP(TM) THREADED FUSION DEVICE AND IS INDICATED FOR SPINAL FUSION PROCEDURES IN SKELETALLY MATURE PATIENTS WTIH DEGENERATIVE DISC DISEASE (DDD) AT ONE LEVEL FROM L2-S1. DDD IS DEFINED AS DISCOGENIC BACK PAIN WITH DEGENERATION OF THE DISC CONFIRMED BY PATIENT HISTORY AND RADIOGRAPHIC STUDIES. THESE DDD PATIENTS MAY ALSO HAVE UP TO GRADE I SPONDYLOLISTHESIS OR RETROLISTHESIS AT THE INVOLVED LEVEL. INTERFIX-RP(TM) THREADED FUSION DEVICES ARE TO BE USED WITH AUTOGENOUS BONE GRAFT AND IMPLANTED VIA AN OPEN ANTERIOR APPROACH. PATIENTS RECEIVING THE INTERFIX-RP(TM) THREADED FUSION DEVICES SHOULD HAVE HAD AT LEAST SIX MONTHS OF NONOPERATIVE TREATMENT PRIOR TO TREATMENT WITH THE INTERFIX-RP(TM) THREADED FUSION DEVICE.

    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