BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Zimmer (LN,LS) - Provisional 17-4 Ph Ss Full Proximal Profile Size 7 94MM

    Reg #: 1424263 · FEI: 3003015552 · Expires 2025
    View on FDA
    Products
    11
    Proprietary Names
    7
    Establishment Types
    1
    Classifications
    11

    Registration Details

    Registration Name
    Isomedix Operations, Inc.
    Registration Number
    1424263
    FEI Number
    3003015552
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2500 Commerce Dr
    City
    Libertyville
    State
    IL
    ZIP
    60048
    Country
    US

    Regulatory Submissions

    510(k) Number
    K150503

    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, Constrained, Cemented Or Uncemented, Metal/Polymer KWZ
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented JDI
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented LPH
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented LWJ
    Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented KWY
    Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive PBI
    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, Hemi-, Femoral, Metal KWL

    Proprietary Names

    Zimmer (LN,LS) - Provisional 17-4 Ph Ss Full Proximal Profile Size 7 94MM Zimmer (LN,LS) - Echo Bi-Metric Microplasty Hip System Standard Femoral Stem Reduced Proximal Profile Zimmer (LN,LS) - High Offset Femoral Stem Full Proximal Profile Ti-6Al-4V 7 Size 94 mm Zimmer (LN,LS) - Standard Femoral Stem Full Proximal Profile Ti-6Al-4V 7 Size 94 mm Zimmer (LN,LS) - High Offset Femoral Stem Reduced Proximal Profile Ti-6Al-4V 7 Size 94 mm Zimmer (LN,LS) - Echo Bi-Metric Microplasty Hip Stem Broach Zimmer (LN,LS) - Provisional 17-4 Ph Ss Reduced Proximal Profile Size 7 94MM

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)