BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Materialise Knee Guide System

    Reg #: 3005718816 · FEI: 3005718816 · Expires 2025
    View on FDA
    Products
    4
    Proprietary Names
    13
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    Materialise USA, LLC.
    Registration Number
    3005718816
    FEI Number
    3005718816
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    44650 Helm Court
    City
    Plymouth
    State
    MI
    ZIP
    48170
    Country
    US

    Regulatory Submissions

    510(k) Number
    K150928

    Owner / Operator

    Firm Name
    MATERIALISE N.V.
    Operator Number
    9029485
    Address
    Technologielaan 15, --
    City
    Leuven
    State
    BE-NOTA
    Postal Code
    3001
    Country
    BE

    Products

    Device Name Product Code
    Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer MBH
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive OIY
    Knee Arthroplasty Implantation System OOG
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer JWH

    Proprietary Names

    Materialise Knee Guide System Materialise Knee Platform Materialise TKA Guide planner Materialise TKA Guide System Bespoke Patient Specific Instruments Materialise TKA Guides Materialise Knee Planner Materialise SurgiCase Knee Planner Materialise Knee Guides Materialise Knee Guide planner Materialise SurgiCase Knee Module Bespoke PSI SurgiCase Knee Planner

    Establishment Types

    Manufacture Medical Device