BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Prosthesis, Intervertebral Disc

    PMA: P110002 · Decision Aug 7, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    73
    Registration Numbers
    73

    Basic Information

    Device Name
    Prosthesis, Intervertebral Disc
    Trade Name
    MOBI-C CERVICAL DISC PROSTHESIS (ONE-LEVEL INDICATION)
    PMA Number
    P110002
    Device Class
    FDA Class 3
    Product Code
    MJO
    Generic Name
    Prosthesis, intervertebral disc
    Medical Specialty
    Unknown
    Advisory Committee
    Orthopedic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    August 7, 2013
    Date Received
    January 14, 2011
    Expedited Review
    N
    Docket Number
    13M-0987

    Advisory Committee Statement

    APPROVAL FOR THE MOBI-C® CERVICAL DISC PROSTHESIS. THIS DEVICE IS INDICATED IN SKELETALLY MATURE PATIENTS FOR RECONSTRUCTION OF THE DISC AT ONE LEVEL FROM C3-C7 FOLLOWING SINGLE-LEVEL DISCECTOMY FOR INTRACTABLERADICULOPATHY (ARM PAIN AND/OR A NEUROLOGICAL DEFICIT) WITH OR WITHOUT NECK PAIN OR MYELOPATHY DUE TO A SINGLE-LEVEL ABNORMALITY LOCALIZED TO THE LEVEL OF THE DISC SPACE AND AT LEAST ONE OF THE FOLLOWING CONDITIONS CONFIRMED BY RADIOGRAPHIC IMAGING (CT, MRI, X-RAYS): HERNIATED NUCLEUS PULPOSUS, SPONDYLOSIS (DEFINED BY THE PRESENCE OF OSTEOPHYTES), AND/OR VISIBLE LOSS OF DISC HEIGHT COMPARED TO ADJACENT LEVELS. THE MOBI-C® CERVICAL DISC PROSTHESIS IS IMPLANTED USING AN ANTERIOR APPROACH. PATIENTS SHOULD HAVE FAILED AT LEAST 6 WEEKS OF CONSERVATIVE TREATMENT ORDEMONSTRATED PROGRESSIVE SIGNS OR SYMPTOMS DESPITE NONOPERATIVE TREATMENT PRIOR TO IMPLANTATION OF THE MOBI-C® CERVICAL DISC PROSTHESIS.

    Classifications

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

    Product Code Device Name
    MJO Prosthesis, Intervertebral Disc