BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Filler, Bone Void, Non-Osteoinduction

    PMA: P860005 · Supplement: S005 · Decision Jul 18, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8

    Basic Information

    Device Name
    Filler, Bone Void, Non-Osteoinduction
    Trade Name
    PRO OSTEON IMPLANT 500 CORALLINE HYDROXYPATITE BONE VOID FILLER (FORMERLY INTERPORE 500)
    PMA Number
    P860005
    Supplement Number
    S005
    Device Class
    FDA Class 3
    Product Code
    MBS
    Generic Name
    Filler, bone void, non-osteoinduction
    Medical Specialty
    Unknown
    Advisory Committee
    Orthopedic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    July 18, 1996
    Date Received
    April 29, 1996
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Other
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A REVISION TO THE POST-MARKET STUDY PROTOCOL

    Classifications

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

    Product Code Device Name
    MBS Filler, Bone Void, Non-Osteoinduction