BEUDAMED
    FDA Registration Active 🇨🇭 Switzerland

    MONARCH Spine System

    Reg #: 3008114965 · FEI: 3008114965 · Expires 2025
    View on FDA
    Products
    6
    Proprietary Names
    11
    Establishment Types
    1
    Classifications
    6

    Registration Details

    Registration Name
    MEDOS INTERNATIONAL SARL
    Registration Number
    3008114965
    FEI Number
    3008114965
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Chemin-Blanc 38
    City
    Le Locle Neuchatel
    Country
    CH

    Regulatory Submissions

    510(k) Number
    K191212

    Owner / Operator

    Firm Name
    Medos International SARL
    Operator Number
    10031083
    Address
    4600 Riverside Drive
    City
    Palm Beach Gardens
    State
    FL
    Postal Code
    33410
    Country
    US
    Correspondent
    Karen Parker

    Products

    Device Name Product Code
    Appliance, Fixation, Spinal Interlaminal KWP
    Growing Rod System PGM
    Cerclage, Fixation JDQ
    Thoracolumbosacral Pedicle Screw System NKB
    Appliance, Fixation, Spinal Intervertebral Body KWQ
    Implant, Fixation Device, Spinal JDN

    Proprietary Names

    MONARCH Spine System TiMX Low Back System EXPEDIUM SFX Cross Connectors EXPEDIUM Fenestrated Screw System E-Z Link Cross Connectors DePuy PULSE Thoracolumbar Screw System EXPEDIUM VERSE Spine System ISOLA Spine System CrossOver Cross Connectors EXPEDIUM Spine System MOSS MIAMI Spine System

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility