BEUDAMED
    FDA Registration Active 🇸🇪 Sweden

    Femoral Epidummy

    Reg #: 3015341893 · FEI: 3015341893 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    14
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    EPISURF OPERATIONS AB
    Registration Number
    3015341893
    FEI Number
    3015341893
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Karlavagen 60
    City
    Stockholm
    Country
    SE

    Regulatory Submissions

    510(k) Number
    K221048

    Owner / Operator

    Firm Name
    Episurf Operations AB
    Operator Number
    10087531
    Address
    Karlavagen 60
    City
    Stockholm
    State
    SE-AB
    Postal Code
    11449
    Country
    SE
    Correspondent
    Ylva Bonde

    Products

    Device Name Product Code
    Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer KRR

    Proprietary Names

    Femoral Epidummy Patellar Epidrill Patellar Epiguide Patellar Epimandrel Femoral Component Femoral Epimandrel Patellar Component Femoral Epidrill Episealer® Patellofemoral System Femoral Epiguide Femoral Adjustment Socket Patellar Epidummy Femoral Drilling Socket Patellar Adjustment Socket

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device