BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Bone Growth, Non-Invasive

    PMA: P850007 · Supplement: S017 · Decision Jan 9, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17

    Basic Information

    Device Name
    Stimulator, Bone Growth, Non-Invasive
    Trade Name
    SPINAL-STIM(R) MODEL 8212C
    PMA Number
    P850007
    Supplement Number
    S017
    Device Class
    FDA Class 3
    Product Code
    LOF
    Generic Name
    Stimulator, bone growth, non-invasive
    Medical Specialty
    Unknown
    Advisory Committee
    Orthopedic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    January 9, 1997
    Date Received
    June 16, 1995
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE MODEL 8000C CONTROL UNIT WHICH IS TO BE USED IN CONJUNCTION WITH THE EXISTING MODEL 212 TREATMENT TRANSDUCERS, AND FOR MINOR MODIFICATIONS TO THE LABELING OF THE PHYSICIAN MANUAL REGARDING PATIENT COMPLIANCE DATA RETRIEVAL AND ERASURE. THE DEVICE WILL BE MARKETED UNDER THE TRADE NAME SPINAL-STIM(R) AND IS INDICATED AS A SURGICAL ADJUNCT FOR SPINAL FUSION OR AS A NONOPERATIVE TREATMENT WHERE AT LEAST NINE MONTHS HAVE ELAPSED SINCE THE LAST SURGERY.

    Classifications

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

    Product Code Device Name
    LOF Stimulator, Bone Growth, Non-Invasive