BEUDAMED
    FDA Registration Active 🇫🇷 France

    Quantum Total Ankle Prosthesis

    Reg #: 3010470577 · FEI: 3010470577 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    IN2BONES, SAS
    Registration Number
    3010470577
    FEI Number
    3010470577
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    28 CHEMIN DU PETIT BOIS
    City
    ECULLY Auvergne-Rhone-Alpes
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K191380

    Owner / Operator

    Firm Name
    IN2BONES, SAS
    Operator Number
    10046803
    Address
    28 CHEMIN DU PETIT BOIS
    City
    ECULLY
    State
    FR-NOTA
    Postal Code
    69130
    Country
    FR

    US Agent

    Business Name
    MRC Global, LLC
    Contact Name
    Christine Scifert
    Address
    9085 E. Mineral Circle, Suite 110
    City
    Centennial
    State
    CO
    ZIP
    80112
    Country
    US
    Email
    [email protected]
    Phone
    901 8318053

    Products

    Device Name Product Code
    Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer HSN

    Proprietary Names

    Quantum Total Ankle Prosthesis

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Develop Specifications But Do Not Manufacture At This Facility