BEUDAMED
    FDA Registration Active 🇦🇺 Australia

    OPTIMIZED ORTHO PTY LTD

    Reg #: 3012916784 · FEI: 3012916784 · Expires 2026
    View on FDA
    Products
    7
    Proprietary Names
    8
    Establishment Types
    3
    Classifications
    7

    Registration Details

    Registration Name
    OPTIMIZED ORTHO PTY LTD
    Registration Number
    3012916784
    FEI Number
    3012916784
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    17 Bridge Street
    City
    Sydney New South Wales
    Country
    AU

    Regulatory Submissions

    510(k) Number
    K190834

    Owner / Operator

    Firm Name
    Corin Group
    Operator Number
    9012268
    Address
    THE CORINIUM CENTRE, --
    City
    CIRENCESTER
    State
    Gloucestershire
    Postal Code
    GL7 1YJ
    Country
    GB
    Correspondent
    Aaron Brunt

    US Agent

    Business Name
    Corin USA
    Contact Name
    Lucinda Gerber
    Address
    480 Paramount Dr
    City
    Raynham
    State
    MA
    ZIP
    02767
    Country
    US
    Email
    [email protected]
    Phone
    772 3212478

    Products

    Device Name Product Code
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented LWJ
    Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate MEH
    Acetabular Cup Orientation System PLW
    Orthopedic Manual Surgical Instrument LXH
    System, Image Processing, Radiological LLZ
    Orthopaedic Surgical Planning And Instrument Guides PBF

    Proprietary Names

    Optimized Position System Functional Hip Analysis (OPS FHA) Optimized Positioning System (OPS) Surgical Instrument Optimized Positioning System (OPS™) Plan Optimized Positioning System (OPS) Plan Optimized Positioning System (OPS) ReView Optimized Positioning System (OPS) Femoral Optimized Positioning System (OPS) Insight

    Establishment Types

    Manufacture Medical Device Export Device to the United States But Perform No Other Operation on Device Develop Specifications But Do Not Manufacture At This Facility