BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    Smooth or threaded metallic bone fixation fastner

    Reg #: 3010400367 · FEI: 3010400367 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    TRIBE MEDICAL GROUP
    Registration Number
    3010400367
    FEI Number
    3010400367
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    595 Industrial Road
    City
    London Ontario
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K132217

    Owner / Operator

    Firm Name
    Tribe Medical Group
    Operator Number
    10082587
    Address
    595 Industrial Road
    City
    London
    State
    Ontario
    Postal Code
    N5V 1V2
    Country
    CA

    US Agent

    Business Name
    Arthrex Inc
    Contact Name
    Barry Dietz
    Address
    1370 Creekside Blvd
    City
    Naples
    State
    FL
    ZIP
    34108
    Country
    US
    Email
    [email protected]
    Phone
    800 9337001

    Products

    Device Name Product Code
    Screw, Fixation, Bone HWC

    Proprietary Names

    Smooth or threaded metallic bone fixation fastner

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device