BEUDAMED
    FDA Registration Active 🇦🇺 Australia

    Precision AI Surgical Planning System (PAI-SPS)

    Reg #: 3031914485 · FEI: 3031914485 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    PRECISION AI PTY LTD
    Registration Number
    3031914485
    FEI Number
    3031914485
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Suite 18, 36 Agnes Street, Fortitude Valley
    City
    Brisbane Queensland
    Country
    AU

    Regulatory Submissions

    510(k) Number
    K233992

    Owner / Operator

    Firm Name
    Precision AI Pty Ltd
    Operator Number
    10091281
    Address
    Suite 18, 36 Agnes Street, Fortitude Valley
    City
    Brisbane
    State
    Queensland
    Postal Code
    4006
    Country
    AU

    US Agent

    Business Name
    Encore Medical
    Contact Name
    Sherri Mellingen
    Address
    9800 Metric Blvd
    City
    Austin
    State
    TX
    ZIP
    78758
    Country
    US
    Email
    [email protected]
    Phone
    512 8329500

    Products

    Device Name Product Code
    Shoulder Prosthesis, Reverse Configuration PHX
    Shoulder Arthroplasty Implantation System QHE
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented KWS

    Proprietary Names

    Precision AI Surgical Planning System (PAI-SPS)

    Establishment Types

    Manufacture Medical Device