BEUDAMED
    FDA Registration Active 🇸🇬 Singapore

    Osteoplug

    Reg #: 3007303685 · FEI: 3007303685 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    OSTEOPORE INTERNATIONAL PTE LTD
    Registration Number
    3007303685
    FEI Number
    3007303685
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2 Tukang Innovation Grove, #09-06 JTC MedTech Hub
    City
    Singapore South West
    Country
    SG

    Regulatory Submissions

    510(k) Number
    K051093

    Owner / Operator

    Firm Name
    Osteopore International Pte Ltd
    Operator Number
    10027129
    Address
    2 Tukang Innovation Grove, #09-06 JTC MedTech Hub
    City
    Singapore
    State
    South West
    Postal Code
    618305
    Country
    SG
    Correspondent
    Luke Ng

    US Agent

    Business Name
    EAS Consulting Group, LLC
    Contact Name
    Victoria Pankovich
    Address
    1700 Diagonal Rd Ste 750
    City
    Alexandria
    State
    VA
    ZIP
    22314
    Country
    US
    Email
    [email protected]
    Phone
    571 4475500

    Products

    Device Name Product Code
    Methyl Methacrylate For Cranioplasty GXP

    Proprietary Names

    Osteoplug Osteoplug-C Osteomesh Osteostrip

    Establishment Types

    Manufacture Medical Device