BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Zimmer (LN) - Arcos One-piece Femoral Revision System

    Reg #: 1450662 · FEI: 1450662 · Expires 2025
    View on FDA
    Products
    11
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    11

    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
    K151603

    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
    Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented OQH
    Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented OQI
    Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive PBI
    Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented KWY
    Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer KWZ
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented LWJ
    Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented OQG
    Prosthesis, Hip, Hemi-, Femoral, Metal KWL
    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 (LN) - Arcos One-piece Femoral Revision System

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)