BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Luna 360

    Reg #: 3008455034 · FEI: 3008455034 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    GENESYS SPINE
    Registration Number
    3008455034
    FEI Number
    3008455034
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1250 S Capital of TX Highway, Building Three, Suite 600
    City
    Austin
    State
    TX
    ZIP
    78746
    Country
    US

    Regulatory Submissions

    510(k) Number
    K100757

    Owner / Operator

    Firm Name
    Genesys Spine
    Operator Number
    10033848
    Address
    1250 Capital of Texas Highway South, Building Three, Suite 600
    City
    Austin
    State
    TX
    Postal Code
    78746
    Country
    US
    Correspondent
    William W Sowers

    Products

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

    Proprietary Names

    Luna 360 TiLock Pedicle Screw System

    Establishment Types

    Manufacture Medical Device