BEUDAMED
    FDA Registration Active 🇺🇸 United States

    PRIMUS Fixture

    Reg #: 3022316560 · FEI: 3022316560 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    INOSYS, INC.
    Registration Number
    3022316560
    FEI Number
    3022316560
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    545 W 45th St Fl 11
    City
    New York
    State
    NY
    ZIP
    10036
    Country
    US

    Regulatory Submissions

    510(k) Number
    K190641

    Owner / Operator

    Firm Name
    INOSYS, INC.
    Operator Number
    10084921
    Address
    545 W 45th St Fl 11, New York, NY 10036
    City
    New York
    State
    NY
    Postal Code
    10036
    Country
    US
    Correspondent
    Chang Bin Lee

    Products

    Device Name Product Code
    Implant, Endosseous, Root-Form DZE

    Proprietary Names

    PRIMUS Fixture PRIMUS Bone Level Fixture Bone Level Fixture

    Establishment Types

    Repack or Relabel Medical Device