BEUDAMED
    FDA Registration Active 🇺🇸 United States

    IDUO G2 BICOMPARTMENTAL KNEE REPAIR SYSTEM

    Reg #: 3004153240 · FEI: 3004153240 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    41
    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
    K093513

    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, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer NPJ

    Proprietary Names

    IDUO G2 BICOMPARTMENTAL KNEE REPAIR SYSTEM IDUO IJIG INSTRUMENTS IDUO KRS IDUO BICOMPARTMENTAL RESURFACING SYSTEM IDUO G2 PARTIAL KNEE REPLACEMENT SYSTEM IDUO G2 KRS IDUO G2 BICOMPARTMENTAL KNEE REPAIR IDUO IDUO G2 IJIGS IDUO KNEE REPAIR SYSTEM IDUO BICOMPARTMENTAL KNEE REPLACEMENT SYSTEM IDUO G2 KNEE RESURFACING IDUO KNEE REPAIR IDUO BICOMPARTMENTAL RESURFACING IDUO IJIG COMPONENTS IDUO BICOMPARTMENTAL KNEE REPAIR IDUO G2 BICOMPARTMENTAL KNEE REPLACEMENT SYSTEM IDUO IJIGS IDUO G2 BICOMPARTMENTAL RESURFACING SYSTEM IDUO G2 KNEE REPAIR SYSTEM IDUO G2 BICOMPARTMENTAL KNEE REPLACEMENT IDUO G2 IJIG COMPONENTS IDUO KNEE REPLACEMENT IDUO KNEE RESURFACING SYSTEM IDUO G2 IJIG ANCILLARY INSTRUMENTS IDUO KNEE REPLACEMENT SYSTEM IDUO G2 KNEE REPLACEMENT IDUO G2 BICOMPARTMENTAL RESURFACING IDUO IJIG ANCILLARY INSTRUMENTS IDUO BICOMPARTMENTAL KNEE REPAIR SYSTEM IDUO G2 KNEE RESURFACING SYSTEM IDUO KNEE RESURFACING IDUO PARTIAL KNEE REPLACEMENT SYSTEM IDUO BICOMPARTMENTAL KNEE REPLACEMENT IDUO G2 IDUO G2 KNEE REPAIR IDUO G2 KNEE REPLACEMENT SYSTEM IDUO G2 IJIG INSTRUMENTS IDUO PARTIAL KNEE REPLACEMENT IDUO G2 PARTIAL KNEE REPLACEMENT TRAY BASE, PATELLA INSTRUMENTS

    Establishment Types

    Manufacture Medical Device