BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SIros Sacroiliac Joint Fusion System

    Reg #: 3008455034 · FEI: 3008455034 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    3
    Classifications
    1

    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
    K233595

    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
    Orthopedic Stereotaxic Instrument OLO

    Proprietary Names

    SIros Sacroiliac Joint Fusion System SIros-O Sacroiliac Joint Fusion System SIros Sacroiliac Joint Fusion System with Navigation SIros-O Sacroiliac Joint Fusion System with Navigation

    Establishment Types

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