BEUDAMED
    FDA Registration Active 🇸🇪 Sweden

    OTS Hip Solution Pinnacle

    Reg #: 3014411622 · FEI: 3014411622 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    ORTOMA AB
    Registration Number
    3014411622
    FEI Number
    3014411622
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Falkenbergsgatan 3
    City
    Gothenburg Vastra Gotaland
    Country
    SE

    Regulatory Submissions

    510(k) Number
    K232140

    Owner / Operator

    Firm Name
    Ortoma AB
    Operator Number
    10091322
    Address
    Falkenbergsgatan 3
    City
    Gothenburg
    State
    Vastra Gotaland
    Postal Code
    41285
    Country
    SE
    Correspondent
    Anders Hahn

    US Agent

    Business Name
    MedTech Review, LLC
    Contact Name
    John Beasley
    Address
    257 Garnet Garden St
    City
    Henderson
    State
    NV
    ZIP
    89015
    Country
    US
    Email
    [email protected]
    Phone
    702 7236889

    Products

    Device Name Product Code
    Orthopedic Stereotaxic Instrument OLO

    Proprietary Names

    OTS Hip Solution Pinnacle OTS Hip Solution Emphasys OTS Hip

    Establishment Types

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