BEUDAMED
    FDA Registration Active 🇸🇪 Sweden

    Osia 2 System

    Reg #: 9616024 · FEI: 3003222064 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Registration Number
    9616024
    FEI Number
    3003222064
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Konstruktionsvagen 14
    City
    Molnlycke Vastra Gotaland
    Country
    SE

    Regulatory Submissions

    510(k) Number
    K220922

    Owner / Operator

    Firm Name
    COCHLEAR AMERICAS
    Operator Number
    9076254
    Address
    10350 Park Meadows Drive
    City
    Lone Tree
    State
    CO
    Postal Code
    80124
    Country
    US

    US Agent

    Business Name
    Cochlear Americas
    Contact Name
    Laura Blair
    Address
    10350 Park Meadows Drive
    City
    Lone Tree
    State
    CO
    ZIP
    80124
    Country
    US
    Email
    [email protected]
    Phone
    800 5235798

    Products

    Device Name Product Code
    Active Implantable Bone Conduction Hearing System PFO

    Proprietary Names

    Osia 2 System

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility