BEUDAMED
    FDA Registration Active 🇮🇪 Ireland

    Ceramic V40™ Femoral Head

    Reg #: 9616680 · FEI: 3002459190 · Expires 2025
    View on FDA
    Products
    12
    Proprietary Names
    22
    Establishment Types
    1
    Classifications
    12

    Registration Details

    Registration Name
    STRYKER IRELAND OSTEONICS
    Registration Number
    9616680
    FEI Number
    3002459190
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Tullagreen Building, IDA Business & Technology Park, Carrigtwohill
    City
    Cork Munster
    Country
    IE

    Regulatory Submissions

    510(k) Number
    K243784

    Owner / Operator

    Firm Name
    STRYKER CORP.
    Operator Number
    1811755
    Address
    4100 East Milham Ave.
    City
    Kalamazoo
    State
    MI
    Postal Code
    49001
    Country
    US

    Products

    Device Name Product Code
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented JDI
    Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate MEH
    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 KWZ
    Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous MBL
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish MAY
    Cement Obturator LZN
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented LPH
    Prosthesis, Hip, Femoral Component, Cemented, Metal JDG
    Prosthesis, Hip, Hemi-, Femoral, Metal KWL

    Proprietary Names

    Ceramic V40™ Femoral Head Accolade Hfx Hip Stems ADM MDM Acetabular Systems Universal Taper Biolox Delta Femoral Head Universal C-Taper Adapter Sleeve Eccentric 10 Degree Cup Insert Crossfire OmniFit Acetabular Inserts Artisan Bone Plug Universal V40™ Taper Adapter Sleeve V40 Taper Alumina Ceramic Head Ceramic C-Taper Femoral Head Restoration Modular System PCA Femoral Head UHR BIPOLAR SYSTEM 12 CROSSFIRE Inserts OmniFit Crossfire Inserts Accolade C Hip Stems PCA Duration Insert ACCOLADE DISTAL SPACER Citation TMZF Hip Stems Trident Acetabular Inserts Accolade II Hip Stems

    Establishment Types

    Manufacture Medical Device