BEUDAMED
    FDA Registration Active 🇦🇺 Australia

    OPS™ Femoral

    Reg #: 3012916784 · FEI: 3012916784 · Expires 2025
    View on FDA
    Products
    4
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    4

    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
    K193545

    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/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO
    Orthopaedic Surgical Planning And Instrument Guides PBF
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented LWJ
    Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate MEH

    Proprietary Names

    OPS™ Femoral Corin Optimized Positioning System (OPS™) Femoral

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device