BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Trident X3 UHMWPE Acetabular Inserts, Restoration ADM and MDM X3 UHMWPE Acetabular Inserts, Accolade II Hip System,

    Reg #: 2249697 · FEI: 3003070421 · Expires 2025
    View on FDA
    Products
    8
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    8

    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
    K182468

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

    Proprietary Names

    Trident X3 UHMWPE Acetabular Inserts, Restoration ADM and MDM X3 UHMWPE Acetabular Inserts, Accolade II Hip System,

    Establishment Types

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