BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Zimmer Persona Personalized Knee System

    Reg #: 3005144609 · FEI: 3005144609 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    EPTAM PLASTICS, LTD
    Registration Number
    3005144609
    FEI Number
    3005144609
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2 Riverside Business Park
    City
    Northfield
    State
    NH
    ZIP
    03276
    Country
    US

    Regulatory Submissions

    510(k) Number
    K172524

    Owner / Operator

    Firm Name
    EPTAM Plastics, Ltd
    Operator Number
    10032547
    Address
    2 Riverside Business Park
    City
    Northfield
    State
    NH
    Postal Code
    03276
    Country
    US
    Correspondent
    Gerry LeBlanc

    Products

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

    Proprietary Names

    Zimmer Persona Personalized Knee System

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)