BEUDAMED
    FDA Registration Active 🇺🇸 United States

    STARband

    Reg #: 1058152 · FEI: 1000222089 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    ORTHOMERICA PRODUCTS, INC.
    Registration Number
    1058152
    FEI Number
    1000222089
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    6333 N Orange Blossom Trl
    City
    ORLANDO
    State
    FL
    ZIP
    32810
    Country
    US

    Regulatory Submissions

    510(k) Number
    K011350

    Owner / Operator

    Firm Name
    ORTHOMERICA PRODUCTS, INC.
    Operator Number
    9007946
    Address
    6333 NORTH ORANGE BLOSSOM, TRAIL
    City
    Orlando
    State
    FL
    Postal Code
    32810
    Country
    US

    Products

    Device Name Product Code
    Orthosis, Cranial, Laser Scan OAN

    Proprietary Names

    STARband STARscanner

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device