BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Regenavate

    Reg #: 3002719998 · FEI: 3002719998 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    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
    K080418

    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
    Bone Grafting Material, Human Source NUN

    Proprietary Names

    Regenavate Regenaform Regenafil AlloSculpt-3D Plus

    Establishment Types

    Manufacture Medical Device