BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SOLACE Sacroiliac Fixation System

    Reg #: 3012429289 · FEI: 3012429289 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    XENIX MEDICAL
    Registration Number
    3012429289
    FEI Number
    3012429289
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    149 W Michigan St
    City
    Orlando
    State
    FL
    ZIP
    32806
    Country
    US

    Regulatory Submissions

    510(k) Number
    K233241

    Owner / Operator

    Firm Name
    Xenix Medical
    Operator Number
    10051846
    Address
    149 W Michigan St.
    City
    Orlando
    State
    FL
    Postal Code
    32806
    Country
    US
    Correspondent
    Ryan Phillips

    Products

    Device Name Product Code
    Sacroiliac Joint Fixation OUR
    Orthopedic Stereotaxic Instrument OLO
    Screw, Fixation, Bone HWC

    Proprietary Names

    SOLACE Sacroiliac Fixation System

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198