BEUDAMED
    FDA Registration Active 🇺🇸 United States

    STERIZO Total Knee System

    Reg #: 3007334927 · FEI: 3007334927 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    CPM Medical Consultants, LLC.
    Registration Number
    3007334927
    FEI Number
    3007334927
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    4343 Sigma Road, Suite 500
    City
    Farmers Branch
    State
    TX
    ZIP
    75244
    Country
    US

    Regulatory Submissions

    510(k) Number
    K142649

    Owner / Operator

    Firm Name
    CPM Medical
    Operator Number
    10029470
    Address
    4343 Sigma Road, Suite 500
    City
    Farmers Branch
    State
    TX
    Postal Code
    75244
    Country
    US
    Correspondent
    Chris Reeg

    Products

    Device Name Product Code
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer JWH

    Proprietary Names

    STERIZO Total Knee System

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility