BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Mainstay Medical (MML US, Inc.)

    Reg #: 3021520203 · FEI: 3021520203 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    3
    Classifications
    2

    Registration Details

    Registration Name
    Mainstay Medical (MML US, Inc.)
    Registration Number
    3021520203
    FEI Number
    3021520203
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    2159 India Street
    City
    San Diego
    State
    CA
    ZIP
    92101
    Country
    US

    Regulatory Submissions

    PMA Number
    P190021

    Owner / Operator

    Firm Name
    Mainstay Medical Limited
    Operator Number
    10076126
    Address
    2159 India St
    City
    San Diego
    State
    CA
    Postal Code
    92101
    Country
    US
    Correspondent
    Sheila Bruschi

    Products

    Device Name Product Code
    Stimulator, Neuromuscular, Lower Back Muscles, Totally Implanted For Pain Relief QLK
    Orthopedic Manual Surgical Instrument LXH

    Proprietary Names

    ReActiv8 ReActiv8 Release Tool

    Establishment Types

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