BEUDAMED
    FDA PMA FDA Class 2 Approved (Reclassification) 🇺🇸 United States

    Calcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation

    PMA: P860005 · Decision Oct 29, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13

    Basic Information

    Device Name
    Calcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation
    Trade Name
    PRO OSTEON IMPLANT 500 HYDROXYAPATITE BONE VOID FILLER
    PMA Number
    P860005
    Device Class
    FDA Class 2
    Product Code
    OIS
    Generic Name
    Calcium salt bone void filler, drillable, non-screw augmentation
    Regulation Number
    888.3045
    Medical Specialty
    Orthopedic
    Advisory Committee
    Orthopedic
    Decision
    Approved (Reclassification)
    Decision Code
    APRL
    Decision Date
    October 29, 1992
    Date Received
    February 10, 1986
    Expedited Review
    N
    Docket Number
    92M-0450

    Classifications

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

    Product Code Device Name
    OIS Calcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation