BEUDAMED
    FDA Registration Active 🇨🇭 Switzerland

    Biolox delta Ceramic Heads, Biolox delta Option Ceramic Heads

    Reg #: 9613350 · FEI: 3005233524 · Expires 2025
    View on FDA
    Products
    8
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    8

    Registration Details

    Registration Name
    ZIMMER GMBH
    Registration Number
    9613350
    FEI Number
    3005233524
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Sulzer Allee 8
    City
    WINTERTHUR Zurich
    Country
    CH

    Regulatory Submissions

    510(k) Number
    K192683

    Owner / Operator

    Firm Name
    ZIMMER GMBH
    Operator Number
    9064978
    Address
    Zahlerweg 4
    City
    Zug
    State
    CH-ZG
    Postal Code
    6300
    Country
    CH

    US Agent

    Business Name
    Zimmer Biomet
    Contact Name
    Holly Seppanen
    Address
    1800 West Center Street
    City
    Warsaw
    State
    IN
    ZIP
    46580
    Country
    US
    Email
    [email protected]
    Phone
    952 8470494

    Products

    Device Name Product Code
    Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented OQI
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented LPH
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish MAY
    Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented OQG
    Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented OQH
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented JDI
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented LWJ

    Proprietary Names

    Biolox delta Ceramic Heads, Biolox delta Option Ceramic Heads

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)