BEUDAMED
    FDA Registration Active 🇦🇺 Australia

    Taperloc Complete Microplasty System

    Reg #: 3035366890 · FEI: 3035366890 · Expires 2025
    View on FDA
    Products
    10
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    10

    Registration Details

    Registration Name
    Zimmer Biomet Pty Ltd
    Registration Number
    3035366890
    FEI Number
    3035366890
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Level 4, 12 Narabang Way, Belrose, NSW
    City
    Sydney New South Wales
    Country
    AU

    Regulatory Submissions

    510(k) Number
    K110400

    Owner / Operator

    Firm Name
    Zimmer Biomet APAC DFE
    Operator Number
    10056128
    Address
    Zimmer Biomet Shanghai
    City
    Shanghai
    State
    CN-SH
    Postal Code
    200051
    Country
    CN

    Products

    Device Name Product Code
    Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented KWY
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented JDI
    Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented OQG
    Prosthesis, Hip, Hemi-, Femoral, Metal KWL
    Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) JDL
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO
    Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) KWA
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented LPH
    Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate MEH
    Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer KWZ

    Proprietary Names

    Taperloc Complete Microplasty System

    Establishment Types

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