BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Zimmer 00-9965-002-18

    Reg #: 1645151 · FEI: 1000118610 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    CENTEX MACHINING, INC.
    Registration Number
    1645151
    FEI Number
    1000118610
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1513 SAM BASS ROAD
    City
    Round Rock
    State
    TX
    ZIP
    78681
    Country
    US

    Regulatory Submissions

    510(k) Number
    K994286

    Owner / Operator

    Firm Name
    Centex Machining by Fathom
    Operator Number
    10061953
    Address
    1513 Sam Bass Rd.
    City
    Round Rock
    State
    TX
    Postal Code
    78681
    Country
    US
    Correspondent
    Donald O Atkins

    Products

    Device Name Product Code
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented LPH
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented LWJ

    Proprietary Names

    Zimmer 00-9965-002-18 Zimmer 00-9965-002-19 Zimmer 00-9965-002-16

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)