BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Filler, Bone Void, Synthetic Peptide

    PMA: P140019 · Decision Nov 3, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7

    Basic Information

    Device Name
    Filler, Bone Void, Synthetic Peptide
    Trade Name
    I-FACTOR PEPTIDE ENHANCED BONE GRAFT
    PMA Number
    P140019
    Device Class
    FDA Class 3
    Product Code
    NOX
    Generic Name
    Filler, bone void, synthetic peptide
    Medical Specialty
    Unknown
    Advisory Committee
    Orthopedic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    November 3, 2015
    Date Received
    August 27, 2014
    Expedited Review
    N
    Docket Number
    15M-4343

    Advisory Committee Statement

    APPROVAL FOR THE I-FACTOR PEPTIDE ENHANCED BONE GRAFT. THIS COMBINATION PRODUCT IS INDICATED FOR USE IN SKELETALLY MATURE PATIENTS FOR RECONSTRUCTION OF A DEGENERATED CERVICAL DISC AT ONE LEVEL FROM C3-C4 TO C6-C7 FOLLOWING SINGLE-LEVEL DISCECTOMY FOR INTRACTABLE RADICULOPATHY (ARM PAIN AND/OR A NEUROLOGICAL DEFICIT), WITH OR WITHOUT NECK PAIN, OR MYELOPATHY DUE TO A SINGLE-LEVEL ABNORMALITY LOCALIZED TO THE DISC SPACE, AND CORRESPONDING TO 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 AS COMPARED TO ADJACENT LEVELS, AFTER FAILURE OF AT LEAST 6 WEEKS OF CONSERVATIVE TREATMENT. I-FACTOR PEPTIDE ENHANCED BONE GRAFT P-15 PUTTY MUST BE USED INSIDE AN ALLOGRAFT BONE RING AND WITH SUPPLEMENTAL ANTERIOR PLATE FIXATION.

    Classifications

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

    Product Code Device Name
    NOX Filler, Bone Void, Synthetic Peptide