BEUDAMED
    FDA Registration Active 🇺🇸 United States

    36MM TRIAL LINER PLUS 0MM OFS

    Reg #: 3005144609 · FEI: 3005144609 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    14
    Establishment Types
    1
    Classifications
    3

    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
    K052906

    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, Shoulder, Semi-Constrained, Metal/Polymer Cemented KWS
    Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented KWT
    Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented HSD

    Proprietary Names

    36MM TRIAL LINER PLUS 0MM OFS 40MM 65D RTNV LINER TRIAL +0MM 36MM 65D RTNV LINER TRIAL +6MM 40MM TRIAL LINER PLUS 0MM OFS 36MM TRIAL LINER PLUS 3MM OFS 40MM TRIAL LINER PLUS 3MM OFS 36MM 65D RTNV LINER TRIAL +3MM 36MM TRIAL LINER PLUS 6MM OFS GLENOSPHERE TRIAL 40MM GLENOSPHERE TRIAL 36MM 40MM 65D RTNV LINER TRIAL +3MM 40MM 65D RTNV LINER TRIAL +6MM 36MM 65D RTNV LINER TRIAL +0MM 40MM TRIAL LINER PLUS 6MM OFS

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)