BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ZIMMER TRABECULAR METAL TOTAL ANKLE -TALUS TRIAL RIGHT SIZE 5

    Reg #: 3005144609 · FEI: 3005144609 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    37
    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
    K120906

    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, Ankle, Semi-Constrained, Cemented, Metal/Polymer HSN

    Proprietary Names

    ZIMMER TRABECULAR METAL TOTAL ANKLE -TALUS TRIAL RIGHT SIZE 5 ZIMMER TRABECULAR METAL TOTAL ANKLE -TIBIA TRIAL SIZE 5 +2 ZIMMER TRABECULAR METAL TOTAL ANKLE -TALUS TRIAL RIGHT SIZE 6 ZIMMER TRABECULAR METAL TOTAL ANKLE -TALUS TRIAL RIGHT SIZE 4 ZIMMER TRABECULAR METAL TOTAL ANKLE -TALUS TRIAL RIGHT SIZE 2 ZIMMER TRABECULAR METAL TOTAL ANKLE - ANTERIOR/POSTERIOR SIZER SZ 4 ZIMMER TRABECULAR METAL TOTAL ANKLE -TIBIA TRIAL SIZE 2 +4 ZIMMER TRABECULAR METAL TOTAL ANKLE -TIBIA TRIAL SIZE 5 +4 ZIMMER TRABECULAR METAL TOTAL ANKLE -TIBIA TRIAL SIZE 3 +0 ZIMMER TRABECULAR METAL TOTAL ANKLE -TIBIA TRIAL SIZE 3 +4 ZIMMER TRABECULAR METAL TOTAL ANKLE - ANTERIOR/POSTERIOR SIZER SZ 3 ZIMMER TRABECULAR METAL TOTAL ANKLE -TALUS TRIAL RIGHT SIZE 1 ZIMMER TRABECULAR METAL TOTAL ANKLE -TALUS TRIAL LEFT SIZE 3 ZIMMER TRABECULAR METAL TOTAL ANKLE -TIBIA TRIAL SIZE 1 +4 ZIMMER TRABECULAR METAL TOTAL ANKLE -TALUS TRIAL LEFT SIZE 5 ZIMMER TRABECULAR METAL TOTAL ANKLE -TIBIA TRIAL SIZE 6 +4 ZIMMER TRABECULAR METAL TOTAL ANKLE -TIBIA TRIAL SIZE 3 +2 ZIMMER TRABECULAR METAL TOTAL ANKLE - ANTERIOR/POSTERIOR SIZER SZ 1 ZIMMER TRABECULAR METAL TOTAL ANKLE - ANTERIOR/POSTERIOR SIZER SZ 2 ZIMMER TRABECULAR METAL TOTAL ANKLE -TIBIA TRIAL SIZE 2 +2 ZIMMER TRABECULAR METAL TOTAL ANKLE -TIBIA TRIAL SIZE 6 +0 ZIMMER TRABECULAR METAL TOTAL ANKLE -TIBIA TRIAL SIZE 1 +0 ZIMMER TRABECULAR METAL TOTAL ANKLE -TALUS TRIAL LEFT SIZE 1 ZIMMER TRABECULAR METAL TOTAL ANKLE -TIBIA TRIAL SIZE 5 +0 ZIMMER TRABECULAR METAL TOTAL ANKLE - ANTERIOR/POSTERIOR SIZER SZ 6 ZIMMER TRABECULAR METAL TOTAL ANKLE - ANTERIOR/POSTERIOR SIZER SZ 5 ZIMMER TRABECULAR METAL TOTAL ANKLE -TALUS TRIAL LEFT SIZE 2 ZIMMER TRABECULAR METAL TOTAL ANKLE -TIBIA TRIAL SIZE 2 +0 ZIMMER TRABECULAR METAL TOTAL ANKLE -TIBIA TRIAL SIZE 1 +2 ZIMMER TRABECULAR METAL TOTAL ANKLE -TALUS TRIAL LEFT SIZE 6 ZIMMER TRABECULAR METAL TOTAL ANKLE - FOOT PLATE ZIMMER TRABECULAR METAL TOTAL ANKLE -TIBIA TRIAL SIZE 4 +0 ZIMMER TRABECULAR METAL TOTAL ANKLE -TIBIA TRIAL SIZE 6 +2 ZIMMER TRABECULAR METAL TOTAL ANKLE -TIBIA TRIAL SIZE 4 +4 ZIMMER TRABECULAR METAL TOTAL ANKLE -TIBIA TRIAL SIZE 4 +2 ZIMMER TRABECULAR METAL TOTAL ANKLE -TALUS TRIAL RIGHT SIZE 3 ZIMMER TRABECULAR METAL TOTAL ANKLE -TALUS TRIAL LEFT SIZE 4

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)