BEUDAMED
    FDA Registration Active 🇫🇷 France

    PLUS PIVOT LINK UNIVERSAL SYSTEM

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

    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
    K021507

    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
    Appliance, Fixation, Spinal Interlaminal KWP
    Orthosis, Spinal Pedicle Fixation MNI
    Orthosis, Spondylolisthesis Spinal Fixation MNH

    Proprietary Names

    PLUS PIVOT LINK UNIVERSAL SYSTEM

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)