BEUDAMED
    FDA Registration Active 🇫🇷 France

    ROI-A Interbody Fusion System- Oblique Implant Design

    Reg #: 8020776 · FEI: 4224 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ANTHOGYR
    Registration Number
    8020776
    FEI Number
    4224
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2237, AVENUE ANDRE LASQUIN
    City
    SALLANCHES Haute-Savoie
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K110327

    Owner / Operator

    Firm Name
    INSTITUT STRAUMANN AG
    Operator Number
    9005052
    Address
    PETER MERIAN-WEG 12
    City
    BASEL
    State
    CH-NOTA
    Postal Code
    CH-4002
    Country
    CH

    US Agent

    Business Name
    Straumann USA, LLC
    Contact Name
    Jennifer Jackson
    Address
    60 Minuteman Road
    City
    Andover
    State
    MA
    ZIP
    01810
    Country
    US
    Email
    [email protected]
    Phone
    978 7472509

    Products

    Device Name Product Code
    Intervertebral Fusion Device With Integrated Fixation, Lumbar OVD

    Proprietary Names

    ROI-A Interbody Fusion System- Oblique Implant Design

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)