BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Materialise PKA Guide planner

    Reg #: 3005718816 · FEI: 3005718816 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    11
    Establishment Types
    1
    Classifications
    2

    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
    K172650

    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, Femorotibial, Non-Constrained, Cemented, Metal/Polymer HSX
    Knee Arthroplasty Implantation System OOG

    Proprietary Names

    Materialise PKA Guide planner Materialise SurgiCase Knee Module Materialise SurgiCase Knee Planner Materialise Knee Planner Materialise PKA Guide System Materialise Knee Guide System Materialise PKA Guides Materialise Knee Platform Materialise Knee Guides Materialise Knee Guide planner SurgiCase Knee Planner

    Establishment Types

    Manufacture Medical Device