BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Xena Top Loading Polyaxial Screw

    Reg #: 3005819474 · FEI: 3005819474 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    4
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    Choice Spine
    Registration Number
    3005819474
    FEI Number
    3005819474
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    400 Erin Drive
    City
    Knoxville
    State
    TN
    ZIP
    37919
    Country
    US

    Regulatory Submissions

    510(k) Number
    K040346

    Owner / Operator

    Firm Name
    CHOICE SPINE, LLC
    Operator Number
    9090881
    Address
    400 ERIN DRIVE
    City
    Knoxville
    State
    TN
    Postal Code
    37919
    Country
    US
    Correspondent
    Kim - Finch

    Products

    Device Name Product Code
    Orthosis, Spondylolisthesis Spinal Fixation MNH
    Orthosis, Spinal Pedicle Fixation MNI

    Proprietary Names

    Xena Top Loading Polyaxial Screw ORIA Xena Spinal Clip System Xena Polyaxial Screw ORIA Xena Top Clip System

    Establishment Types

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