BEUDAMED
    FDA Registration Active 🇨🇭 Switzerland

    NS053; NAVIPLAN - CT Planning Software for Total Hip Replacement

    Reg #: 3017123055 · FEI: 3017123055 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    NAVISWISS AG
    Registration Number
    3017123055
    FEI Number
    3017123055
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    stahlrain 2
    City
    Brugg Aargau
    Country
    CH

    Regulatory Submissions

    510(k) Number
    K211429

    Owner / Operator

    Firm Name
    Naviswiss AG
    Operator Number
    10076290
    Address
    stahlrain 2
    City
    Brugg
    State
    CH-NOTA
    Postal Code
    5200
    Country
    CH
    Correspondent
    Jan Stifter

    US Agent

    Business Name
    confinis USA Inc.
    Contact Name
    Alfred Lerch
    Address
    600 Park Offices Drive Suite 300, Unit #50
    City
    Durham
    State
    NC
    ZIP
    27709
    Country
    US
    Email
    [email protected]
    Phone
    910 2289391

    Products

    Device Name Product Code
    System, Image Processing, Radiological LLZ

    Proprietary Names

    NS053; NAVIPLAN - CT Planning Software for Total Hip Replacement

    Establishment Types

    Manufacture Medical Device