BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Genesys Spine: GL216 - NAV Pedicle Screw Driver - TiLock Pedicle Screw System

    Reg #: 3009887475 · FEI: 3009887475 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    Complexus Medical
    Registration Number
    3009887475
    FEI Number
    3009887475
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    55980 Russell Industrial Pkwy
    City
    Mishawaka
    State
    IN
    ZIP
    46545
    Country
    US

    Regulatory Submissions

    510(k) Number
    K100757

    Owner / Operator

    Firm Name
    Complexus Medical
    Operator Number
    10042212
    Address
    55980 Russell Industrial Parkway
    City
    Mishawaka
    State
    IN
    Postal Code
    46545
    Country
    US
    Correspondent
    Michael Behrens

    Products

    Device Name Product Code
    Orthosis, Spinal Pedicle Fixation MNI
    Thoracolumbosacral Pedicle Screw System NKB
    Orthosis, Spondylolisthesis Spinal Fixation MNH

    Proprietary Names

    Genesys Spine: GL216 - NAV Pedicle Screw Driver - TiLock Pedicle Screw System Genesys Spine: GLC414 - MIS Friction Clip Driver - TiLock Pedicle Screw System Genesys Spine: GLC430 - MIS Extended Rod Caliper - TiLock Pedicle Screw System Genesys Spine: GLC414 - MIS TTS Rod Inserter - TiLock Pedicle Screw System

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)