BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Nemcomed FW LLC (d.b.a Avalign Instruments & Implants)

    Reg #: 3006128100 · FEI: 3006128100 · Expires 2025
    View on FDA
    Products
    9
    Proprietary Names
    0
    Establishment Types
    1
    Classifications
    9

    Registration Details

    Registration Name
    Nemcomed FW LLC (d.b.a Avalign Instruments & Implants)
    Registration Number
    3006128100
    FEI Number
    3006128100
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    8727 & 8414 Clinton Park Dr
    City
    FORT WAYNE
    State
    IN
    ZIP
    46825
    Country
    US

    Regulatory Submissions

    510(k) Number
    K090757

    Owner / Operator

    Firm Name
    Avalign Instruments & Implants
    Operator Number
    9008280
    Address
    8727 Clinton Park Drive, --
    City
    Fort Wayne
    State
    IN
    Postal Code
    46825
    Country
    US
    Correspondent
    Jeff Robinson

    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, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented KWY
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish MAY
    Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) KWA
    Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) JDL
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO
    Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate MEH
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented JDI

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)