BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    MEDYSSEY CO., LTD.

    Reg #: 3007485169 · FEI: 3007485169 · Expires 2026
    View on FDA
    Products
    13
    Proprietary Names
    13
    Establishment Types
    1
    Classifications
    13

    Registration Details

    Registration Name
    MEDYSSEY CO., LTD.
    Registration Number
    3007485169
    FEI Number
    3007485169
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    129, Hanbang expo-ro, Jecheon-si, Chungcheogbuk-do
    City
    Jecheon-si Chungbuk
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K171526

    Owner / Operator

    Firm Name
    Medyssey Co., Ltd.
    Operator Number
    10028329
    Address
    129, Hanbang expo-ro
    City
    Jecheon-City
    State
    Chungbuk
    Postal Code
    27116
    Country
    KR

    Products

    Device Name Product Code
    Tray, Surgical LRP
    Thoracolumbosacral Pedicle Screw System NKB
    Intervertebral Fusion Device With Bone Graft, Lumbar MAX
    Appliance, Fixation, Spinal Interlaminal KWP
    Posterior Cervical Screw System NKG
    Appliance, Fixation, Spinal Intervertebral Body KWQ
    Orthopedic Stereotaxic Instrument OLO
    Orthopedic Manual Surgical Instrument LXH
    Orthosis, Spinal Pedicle Fixation MNI
    Orthosis, Spondylolisthesis Spinal Fixation MNH
    Intervertebral Fusion Device With Bone Graft, Cervical ODP
    Intervertebral Fusion Device With Integrated Fixation, Cervical OVE
    Injector, Vertebroplasty (Does Not Contain Cement) OAR

    Proprietary Names

    Medyssey Tray Zenius™, lliad™ and Kora™ Spinal Fixation Systems Medussa-PL Cage Zenius™, Iliad™ and Kora™ Spinal Fixation Systems Iliad, Kora and Zenius Spinal System - Hook connector Athena Cervical Plate System Varian Cage Zenius Spinal System Medyssey Navigation System Medyssey Surgical instrument ARTeMIS Spinal System NeckTune™ 3D SA Cervical Cage Athena III Cervical Plate System

    Establishment Types

    Manufacture Medical Device