BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Filler, Bone Void, Non-Osteoinduction

    PMA: P860005 · Supplement: S010 · Decision Jan 8, 1998
    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 POROUS CORALLINE HYDROXYAPATITE BONE GRAFT SUBSTITUTE
    PMA Number
    P860005
    Supplement Number
    S010
    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
    January 8, 1998
    Date Received
    November 18, 1997
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for a change to the name of the product from "Bone Void Filler" to "Bone Graft Substitute." The device, as modified in designation, will be marketed under the trade name "Pro Osteon Implant 500 Porous Coralline Hydroxyapatite Bone Graft Substitute Blocks and Granules," and is indicated for the same indications approved in the original PMA and in P860006/S002.

    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