BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Unison-C Anterior Cervical Fixation System

    Reg #: 3005031160 · FEI: 3005031160 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Xtant Medical Holdings, Inc.
    Registration Number
    3005031160
    FEI Number
    3005031160
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    664 Cruiser Lane
    City
    Belgrade
    State
    MT
    ZIP
    59714
    Country
    US

    Regulatory Submissions

    510(k) Number
    K152793

    Owner / Operator

    Firm Name
    Xtant Medical Holdings, Inc.
    Operator Number
    10028385
    Address
    664 Cruiser Lane
    City
    Belgrade
    State
    MT
    Postal Code
    59714
    Country
    US
    Correspondent
    Rebecca Lennemann

    Products

    Device Name Product Code
    Intervertebral Fusion Device With Integrated Fixation, Cervical OVE

    Proprietary Names

    Unison-C Anterior Cervical Fixation System

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198