BEUDAMED
    FDA Registration Active 🇨🇳 China

    Vivacit-E Vitamin E Highly Crosslinked Polyethylene Liners

    Reg #: 3006801265 · FEI: 3006801265 · Expires 2025
    View on FDA
    Products
    6
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    6

    Registration Details

    Registration Name
    Zhejiang Biomet Medical Products Co., Ltd.
    Registration Number
    3006801265
    FEI Number
    3006801265
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    980 Shenli Road
    City
    Jinhua Zhejiang
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K120370

    Owner / Operator

    Firm Name
    Biomet, Inc.
    Operator Number
    1825034
    Address
    56 East Bell Dr., PO Box 587
    City
    Warsaw
    State
    IN
    Postal Code
    46582
    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
    Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented OQI
    Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented OQH
    Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented OQG
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented JDI
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented LPH

    Proprietary Names

    Vivacit-E Vitamin E Highly Crosslinked Polyethylene Liners

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)