BEUDAMED
    FDA Registration Active 🇨🇱 Chile

    SIRIUS FEMORAL STEM

    Reg #: 3014302784 · FEI: 3014302784 · Expires 2025
    View on FDA
    Products
    13
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    13

    Registration Details

    Registration Name
    BIOMET CHILE S.A.
    Registration Number
    3014302784
    FEI Number
    3014302784
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Av. Santa Clara No. 085 Floor 7, HUECHURABA
    City
    Santiago de Chile Region Metropolitana
    Country
    CL

    Regulatory Submissions

    510(k) Number
    K130610

    Owner / Operator

    Firm Name
    ZimmerBiomet Americas DFE
    Operator Number
    10056779
    Address
    1800 W Center St.
    City
    Warsaw
    State
    IN
    Postal Code
    46580
    Country
    US

    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
    Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate MEH
    Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented KWY
    Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented OQI
    Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer KWZ
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO
    Prosthesis, Hip, Hemi-, Femoral, Metal Ball LZY
    Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented OQH
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented JDI
    Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented OQG
    Prosthesis, Hip, Femoral Component, Cemented, Metal JDG
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented LPH
    Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive PBI
    Prosthesis, Hip, Hemi-, Femoral, Metal KWL

    Proprietary Names

    SIRIUS FEMORAL STEM

    Establishment Types

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