BEUDAMED
    FDA Registration Active 🇬🇧 United Kingdom

    Episealer Knee Revision Guide

    Reg #: 3027556146 · FEI: 3027556146 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    7
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    PROTOTAL UK
    Registration Number
    3027556146
    FEI Number
    3027556146
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Unit 14-15, Fulton Court, Greenham Business Park
    City
    Thatcham West Berkshire
    Country
    GB

    Regulatory Submissions

    510(k) Number
    K221048

    Owner / Operator

    Firm Name
    Prototal UK
    Operator Number
    10088307
    Address
    Unit 14-15, Fulton Court, Greenham Business Park
    City
    Thatcham
    State
    West Berkshire
    Postal Code
    RG196HD
    Country
    GB
    Correspondent
    Paul Dicker

    Products

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

    Proprietary Names

    Episealer Knee Revision Guide Patellar Epiguide Femoral Epimandrel Patellar Epimandrel Femoral Epidummy Patellar Epidummy Femoral Epiguide

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)