BEUDAMED
    FDA Registration Active 🇺🇸 United States

    IUNI UNICONDYLAR KNEE REPAIR SYSTEM

    Reg #: 3004153240 · FEI: 3004153240 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    20
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ConforMIS, Inc.
    Registration Number
    3004153240
    FEI Number
    3004153240
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    600 Research Dr
    City
    Wilmington
    State
    MA
    ZIP
    01887
    Country
    US

    Regulatory Submissions

    510(k) Number
    K043570

    Owner / Operator

    Firm Name
    restor3d, Inc.
    Operator Number
    9058483
    Address
    4001 NC-54, Suite 3160
    City
    Durham
    State
    NC
    Postal Code
    27709
    Country
    US
    Correspondent
    Brianna Prindle

    Products

    Device Name Product Code
    Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer HSX

    Proprietary Names

    IUNI UNICONDYLAR KNEE REPAIR SYSTEM IUNI KRS IUNI PARTIAL KNEE REPLACEMENT IUNI UNICONDYLAR KNEE REPAIR IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEM IUNI IJIGS IUNI IUNI KNEE RESURFACING IUNI KNEE REPAIR SYSTEM IUNI KNEE REPLACEMENT IUNI UNICONDYLAR KNEE RESURFACING IUNI UNICONDYLAR KNEE RESURFACING SYSTEM IUNI UNICONDYLAR KNEE REPLACEMENT IUNI KNEE RESURFACING SYSTEM IUNI IJIG COMPONENTS IUNI KNEE REPAIR IUNI PARTIAL KNEE REPLACEMENT SYSTEM IUNI IJIG ANCILLARY INSTRUMENTS IUNI IJIG INSTRUMENTS IUNI KNEE REPLACEMENT SYSTEM

    Establishment Types

    Manufacture Medical Device