BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Apex Revision Knee System

    Reg #: 1226188 · FEI: 3008342029 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    OMNIlifeScience, Inc.
    Registration Number
    1226188
    FEI Number
    3008342029
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    480 Paramount Dr
    City
    Raynham
    State
    MA
    ZIP
    02767
    Country
    US

    Regulatory Submissions

    510(k) Number
    K112891

    Owner / Operator

    Firm Name
    OMNI Life Science, Inc.
    Operator Number
    9038042
    Address
    480 Paramount Drive
    City
    Raynham
    State
    MA
    Postal Code
    02767
    Country
    US

    Products

    Device Name Product Code
    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

    Apex Revision Knee System

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility