BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ONYX MEDICAL LLC

    Reg #: 1043653 · FEI: 1043653 · Expires 2025
    View on FDA
    Products
    13
    Proprietary Names
    0
    Establishment Types
    1
    Classifications
    13

    Registration Details

    Registration Name
    ONYX MEDICAL LLC
    Registration Number
    1043653
    FEI Number
    1043653
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1800 North Shelby Oaks Drive
    City
    MEMPHIS
    State
    TN
    ZIP
    38134
    Country
    US

    Regulatory Submissions

    510(k) Number
    K123598

    Owner / Operator

    Firm Name
    Elos Medtech Onyx
    Operator Number
    9002922
    Address
    1800 N Shelby Oaks Dr, --
    City
    Memphis
    State
    TN
    Postal Code
    38134
    Country
    US
    Correspondent
    Jodie L Gilmore

    Products

    Device Name Product Code
    Prosthesis, Hip, Hemi-, Femoral, Metal Ball LZY
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented LWJ
    Cerclage, Fixation JDQ
    Mesh, Surgical, Acetabular, Hip, Prosthesis JDJ
    Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer KWZ
    Prosthesis, Hip, Hemi-, Femoral, Metal KWL
    Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate MEH
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented LPH
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO
    Prosthesis, Hip, Femoral Component, Cemented, Metal JDG
    Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous MBL
    Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented KWY
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented JDI

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)