BEUDAMED
    FDA Registration Active 🇺🇸 United States

    OrthoPak 2 Bone Growth Stimulator S

    Reg #: 2242816 · FEI: 2242816 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    EBI, LLC
    Registration Number
    2242816
    FEI Number
    2242816
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1 Gatehall Rd., Suite 303
    City
    PARSIPPANY
    State
    NJ
    ZIP
    07054
    Country
    US

    Regulatory Submissions

    PMA Number
    P850022

    Owner / Operator

    Firm Name
    HighRidge Medical
    Operator Number
    2242816
    Address
    1 Gatehall Drive, Suite 303
    City
    Parsippany
    State
    NJ
    Postal Code
    07054
    Country
    US
    Correspondent
    Robert W Kokowitz

    Products

    Device Name Product Code
    Stimulator, Bone Growth, Non-Invasive LOF

    Proprietary Names

    OrthoPak 2 Bone Growth Stimulator S SpinalPak II Bone Growth Stimulator Biomet OrthoPak Non-invasive Bone Growth Stimulator System Biomet Spinalpak Non-invasive Spine Fusion Stimulator System

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility