BEUDAMED
    FDA Registration Active 🇺🇸 United States

    IUNI G2 KRS

    Reg #: 3004153240 · FEI: 3004153240 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    40
    Establishment Types
    1
    Classifications
    2

    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
    K111916

    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
    Knee Arthroplasty Implantation System OOG

    Proprietary Names

    IUNI G2 KRS IUNI UNICONDYLAR KNEE RESURFACING IUNI G2 UNICONDYLAR KNEE REPLACEMENT IUNI UNICONDYLAR KNEE REPAIR SYSTEM IUNI IJIG ANCILLARY INSTRUMENTS IUNI G2 IJIG INSTRUMENTS IUNI G2 IUNI KNEE RESURFACING IUNI G2 UNICONDYLAR KNEE REPAIR IUNI G2 UNICONDYLAR KNEE RESURFACING SYSTEM IUNI G2 KNEE REPLACEMENT SYSTEM IUNI G2 PARTIAL KNEE REPLACEMENT IUNI G2 KNEE REPAIR SYSTEM IUNI G2 IJIG COMPONENTS IUNI UNICONDYLAR KNEE REPLACEMENT IUNI IJIG COMPONENTS IUNI G2 IJIGS IUNI KNEE REPLACEMENT IUNI UNICONDYLAR KNEE REPAIR IUNI PARTIAL KNEE REPLACEMENT IUNI PARTIAL KNEE REPLACEMENT SYSTEM IUNI G2 UNICONDYLAR KNEE REPAIR SYSTEM IUNI UNICONDYLAR KNEE RESURFACING SYSTEM IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEM IUNI G2 UNICONDYLAR KNEE RESURFACING IUNI G2 UNICONDYLAR KNEE REPLACEMENT SYSTEM IUNI G2 KNEE RESURFACING SYSTEM IUNI G2 PARTIAL KNEE REPLACEMENT SYSTEM IUNI G2 KNEE RESURFACING IUNI KNEE RESURFACING SYSTEM IUNI G2 KNEE REPAIR IUNI KNEE REPLACEMENT SYSTEM IUNI G2 IJIG ANCILLARY INSTRUMENTS IUNI KNEE REPAIR SYSTEM IUNI IUNI G2 KNEE REPLACEMENT IUNI KRS IUNI KNEE REPAIR IUNI IJIG INSTRUMENTS IUNI IJIGS

    Establishment Types

    Manufacture Medical Device