BEUDAMED
    FDA Registration Active 🇺🇸 United States

    OvertureTi Knee Resurfacing System

    Reg #: 3027737826 · FEI: 3027737826 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    OVERTURE ORTHOPAEDICS
    Registration Number
    3027737826
    FEI Number
    3027737826
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    5 Peters Canyon Rd Ste 160
    City
    Irvine
    State
    CA
    ZIP
    92606
    Country
    US

    Regulatory Submissions

    510(k) Number
    K242746

    Owner / Operator

    Firm Name
    Overture Orthopaedics
    Operator Number
    10088496
    Address
    5 Peters Canyon Road, Suite 160
    City
    Irvine
    State
    CA
    Postal Code
    92606
    Country
    US
    Correspondent
    James Kim

    Products

    Device Name Product Code
    Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer HSX

    Proprietary Names

    OvertureTi Knee Resurfacing System

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility