BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Smith and Nephew Hip System

    Reg #: 3009888740 · FEI: 3009888740 · Expires 2025
    View on FDA
    Products
    13
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    13

    Registration Details

    Registration Name
    Orchid Orthopedic Solutions Alabama LLC
    Registration Number
    3009888740
    FEI Number
    3009888740
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    331 City Park Dr SE
    City
    Arab
    State
    AL
    ZIP
    35016
    Country
    US

    Regulatory Submissions

    510(k) Number
    K123598

    Owner / Operator

    Firm Name
    Orchid Orhopedics
    Operator Number
    10042268
    Address
    331 City Park Dr. SE
    City
    Arab
    State
    AL
    Postal Code
    35016
    Country
    US
    Correspondent
    Joel Roth

    Products

    Device Name Product Code
    Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer KWZ
    Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented KWY
    Prosthesis, Hip, Hemi-, Femoral, Metal Ball LZY
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO
    Mesh, Surgical, Acetabular, Hip, Prosthesis JDJ
    Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous MBL
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented LWJ
    Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate MEH
    Cerclage, Fixation JDQ
    Prosthesis, Hip, Femoral Component, Cemented, Metal JDG
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented JDI
    Prosthesis, Hip, Hemi-, Femoral, Metal KWL
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented LPH

    Proprietary Names

    Smith and Nephew Hip System

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)