BEUDAMED
    FDA Registration Active 🇦🇺 Australia

    Optimized Positioning System (OPS™) ReView

    Reg #: 3012916784 · FEI: 3012916784 · Expires 2025
    View on FDA
    Products
    5
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    5

    Registration Details

    Registration Name
    OPTIMIZED ORTHO PTY LTD
    Registration Number
    3012916784
    FEI Number
    3012916784
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    17 Bridge Street
    City
    Sydney New South Wales
    Country
    AU

    Regulatory Submissions

    510(k) Number
    K193042

    Owner / Operator

    Firm Name
    Optimized Ortho Pty Ltd
    Operator Number
    10052254
    Address
    17 Bridge Street
    City
    Sydney
    State
    New South Wales
    Postal Code
    2073
    Country
    AU

    Products

    Device Name Product Code
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented LWJ
    Acetabular Cup Orientation System PLW
    System, Image Processing, Radiological LLZ
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO
    Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate MEH

    Proprietary Names

    Optimized Positioning System (OPS™) ReView OPSReView™

    Establishment Types

    Manufacture Medical Device