BEUDAMED
    FDA Registration Active 🇺🇸 United States

    External Fixation System

    Reg #: 3010131978 · FEI: 3010131978 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ORBIS MEDICAL, LLC
    Registration Number
    3010131978
    FEI Number
    3010131978
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    17125 SW 81st Ct
    City
    Palmetto Bay
    State
    FL
    ZIP
    33157
    Country
    US

    Regulatory Submissions

    510(k) Number
    K122208

    Owner / Operator

    Firm Name
    Orbis Medical, LLC
    Operator Number
    10043155
    Address
    17125 SW 81 Court
    City
    Palmetto Bay
    State
    FL
    Postal Code
    33157
    Country
    US
    Correspondent
    Christopher D Endara

    Products

    Device Name Product Code
    System, External Fixator (With Metallic Invasive Components) NDK

    Proprietary Names

    External Fixation System

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility