BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    The Optimotion Blue Total Knee System

    Reg #: 3014162916 · FEI: 3014162916 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    PRECISION ADM
    Registration Number
    3014162916
    FEI Number
    3014162916
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Unit 3 - 725 Black Diamond Boulevard
    City
    Winnipeg Manitoba
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K191084

    Owner / Operator

    Firm Name
    Precision ADM
    Operator Number
    10091080
    Address
    Unit 3 - 725 Black Diamond Boulevard
    City
    Winnipeg
    State
    Manitoba
    Postal Code
    R2J 4M7
    Country
    CA

    US Agent

    Business Name
    Dawa Medical LLC
    Contact Name
    Stephan Toupin
    Address
    7320 NW 12th Street Suite 103
    City
    Miami
    State
    FL
    ZIP
    33126
    Country
    US
    Email
    [email protected]
    Phone
    786 7311159

    Products

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

    Proprietary Names

    The Optimotion Blue Total Knee System

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)