BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Ceramic V40™ Femoral Head

    Reg #: 2249697 · FEI: 3003070421 · Expires 2025
    View on FDA
    Products
    12
    Proprietary Names
    22
    Establishment Types
    2
    Classifications
    12

    Registration Details

    Registration Name
    HOWMEDICA OSTEONICS CORP
    Registration Number
    2249697
    FEI Number
    3003070421
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    325 CORPORATE DR.
    City
    MAHWAH
    State
    NJ
    ZIP
    07430
    Country
    US

    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

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device