BEUDAMED
    FDA Registration Active 🇺🇸 United States

    4 Peg Mod Glen Trial Lt Aug 4

    Reg #: 3005144609 · FEI: 3005144609 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    10
    Establishment Types
    1
    Classifications
    2

    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
    K193180

    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

    Proprietary Names

    4 Peg Mod Glen Trial Lt Aug 4 4 Peg Mod Glen Trial Rt Aug 2 4 Peg Mod Glen Trial Lt Aug 2 4 Peg Mod Glen Trial Lt Aug 3 4 Peg Mod Glen Trial Lt Aug 5 4 Peg Mod Glen Trial Rt Aug 4 4-Peg Aug Reamer Guide Left 4 Peg Mod Glen Trial Rt Aug 5 4 Peg Mod Glen Trial Rt Aug 3 4-Peg Aug Reamer Guide Right

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)