BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Zimmer Biomet

    Reg #: 3015526568 · FEI: 3015526568 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    TRIANGLE MACHINE, INC.
    Registration Number
    3015526568
    FEI Number
    3015526568
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3702 W. Sample Street Suite 1125
    City
    South Bend
    State
    IN
    ZIP
    46619
    Country
    US

    Regulatory Submissions

    510(k) Number
    K120906

    Owner / Operator

    Firm Name
    Triangle Machine, Inc.
    Operator Number
    10060587
    Address
    3702 W. Sample Street Suite 1125
    City
    South Bend
    State
    IN
    Postal Code
    46619
    Country
    US
    Correspondent
    Mai Tran

    Products

    Device Name Product Code
    Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer HSN

    Proprietary Names

    Zimmer Biomet TIBIA ALIGNMENT ROD CENTER PROBE

    Establishment Types

    Manufacture Medical Device