BEUDAMED
    FDA Registration Active 🇫🇷 France

    Idys® ALIF 3DTi

    Reg #: 3008992889 · FEI: 3008992889 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    3
    Classifications
    2

    Registration Details

    Registration Name
    CLARIANCE-SAS
    Registration Number
    3008992889
    FEI Number
    3008992889
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    18, rue Robespierre
    City
    BEAURAINS Hauts-de-France
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K200919

    Owner / Operator

    Firm Name
    CLARIANCE-SAS
    Operator Number
    10043711
    Address
    18, rue Robespierre
    City
    BEAURAINS
    State
    Pas-de-Calais
    Postal Code
    62217
    Country
    FR

    US Agent

    Business Name
    Clariance, Inc.
    Contact Name
    Sylvain CHAMBAT
    Address
    2547 Farrington St
    City
    Dallas
    State
    TX
    ZIP
    75207
    Country
    US
    Email
    [email protected]
    Phone
    773 8327554

    Products

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

    Proprietary Names

    Idys® ALIF 3DTi

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device