BEUDAMED
    FDA Registration Active 🇮🇪 Ireland

    Zimmer (WP) - LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE ELEVATED LINERS

    Reg #: 3010173425 · FEI: 3002807036 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    Synergy Health Westport Ltd
    Registration Number
    3010173425
    FEI Number
    3002807036
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Lodge Road
    City
    Westport Mayo
    Country
    IE

    Regulatory Submissions

    510(k) Number
    K093846

    Owner / Operator

    Firm Name
    STERIS Corporation
    Operator Number
    10042227
    Address
    5960 Heisley Road
    City
    Mentor
    State
    OH
    Postal Code
    44060
    Country
    US

    US Agent

    Business Name
    Synergy Health
    Contact Name
    Becky Aldhizer
    Address
    5960 Heisley Rd
    City
    Mentor
    State
    OH
    ZIP
    44060
    Country
    US
    Email
    [email protected]
    Phone
    440 3927490

    Products

    Device Name Product Code
    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

    Zimmer (WP) - LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE ELEVATED LINERS

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)