BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Opteform® paste

    Reg #: 3002719998 · FEI: 3002719998 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    7
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    RTI Surgical, Inc. (dba RTI Biologics, Inc.)
    Registration Number
    3002719998
    FEI Number
    3002719998
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    11621 Research Circle
    City
    ALACHUA
    State
    FL
    ZIP
    32615
    Country
    US

    Regulatory Submissions

    510(k) Number
    K043421

    Owner / Operator

    Firm Name
    RTI Surgical, Inc. (dba RTI Biologics, Inc.)
    Operator Number
    1641375
    Address
    11621 Research Circle
    City
    Alachua
    State
    FL
    Postal Code
    32615
    Country
    US
    Correspondent
    Amanda LoGuidice

    Products

    Device Name Product Code
    Filler, Bone Void, Calcium Compound MQV

    Proprietary Names

    Opteform® paste ProSpace DBM-D RTI Allograft Paste Altiva DBM Osteofil® paste Synergent DBM with CCC BioSet® paste

    Establishment Types

    Manufacture Medical Device