BEUDAMED
    FDA Registration Active 🇫🇷 France

    ROI-T Implant System

    Reg #: 8020776 · FEI: 4224 · Expires 2025
    View on FDA
    Products
    9
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    9

    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
    K121103

    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 Bone Graft, Cervical ODP
    Spinal Vertebral Body Replacement Device MQP
    Intervertebral Fusion Device With Integrated Fixation, Lumbar OVD
    Orthosis, Spondylolisthesis Spinal Fixation MNH
    Intervertebral Fusion Device With Integrated Fixation, Cervical OVE
    Intervertebral Fusion Device With Bone Graft, Lumbar MAX
    Thoracolumbosacral Pedicle Screw System NKB
    Appliance, Fixation, Spinal Interlaminal KWP
    Orthosis, Spinal Pedicle Fixation MNI

    Proprietary Names

    ROI-T Implant System ROI-C Implant System ROI-A Implant System ROI Implant System EasySpine Posterior Spinal System MC+ Implant System

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)