BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Zimmer (LN) -ARCOM XL POLYETHYLENE LINERS AND 38/40 FEMORAL HEADS

    Reg #: 1450662 · FEI: 1450662 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Isomedix Operations, Inc.
    Registration Number
    1450662
    FEI Number
    1450662
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1880 Industrial Dr
    City
    Libertyville
    State
    IL
    ZIP
    60048
    Country
    US

    Regulatory Submissions

    510(k) Number
    K062997

    Owner / Operator

    Firm Name
    STERIS Corporation
    Operator Number
    1527821
    Address
    5960 Heisley Rd, --
    City
    Mentor
    State
    OH
    Postal Code
    44060
    Country
    US

    Products

    Device Name Product Code
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO

    Proprietary Names

    Zimmer (LN) -ARCOM XL POLYETHYLENE LINERS AND 38/40 FEMORAL HEADS

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)