BEUDAMED
    FDA Registration Active 🇺🇸 United States

    iUni Unicondylar Knee Replacement System

    Reg #: 3004153240 · FEI: 3004153240 · Expires 2025
    View on FDA
    Products
    5
    Proprietary Names
    4
    Establishment Types
    2
    Classifications
    5

    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
    K193105

    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, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive OIY
    Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer HSX
    Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer NPJ
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer JWH
    Knee Arthroplasty Implantation System OOG

    Proprietary Names

    iUni Unicondylar Knee Replacement System iTotal PS Knee Replacement System iTotal CR Knee Replacement System iDuo Bicompartmental Knee Repair System

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device