BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ELEOS Limb Salvage System with BioGrip

    Reg #: 1836357 · FEI: 3003064967 · Expires 2025
    View on FDA
    Products
    5
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    5

    Registration Details

    Registration Name
    C+A TOOL ENGINEERING, INC.
    Registration Number
    1836357
    FEI Number
    3003064967
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    4100 N. US 33
    City
    Churubusco
    State
    IN
    ZIP
    46723
    Country
    US

    Regulatory Submissions

    510(k) Number
    K203090

    Owner / Operator

    Firm Name
    MinebeaMitsumi Inc.
    Operator Number
    10055758
    Address
    3-9-6 Mita
    City
    Minato-ku
    State
    Tokyo
    Postal Code
    108-8330
    Country
    JP

    Products

    Device Name Product Code
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented JDI
    Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer KRO
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer JWH
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented LPH
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO

    Proprietary Names

    ELEOS Limb Salvage System with BioGrip

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)