BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Ltd Polyaxial Fixation System

    Reg #: 3009051471 · FEI: 3009051471 · Expires 2025
    View on FDA
    Products
    4
    Proprietary Names
    1
    Establishment Types
    4
    Classifications
    4

    Registration Details

    Registration Name
    CTL Medical Corporation
    Registration Number
    3009051471
    FEI Number
    3009051471
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2052 McKenzie Drive, Building 1
    City
    Carrollton
    State
    TX
    ZIP
    75006
    Country
    US

    Regulatory Submissions

    510(k) Number
    K041625

    Owner / Operator

    Firm Name
    CTL Amedica
    Operator Number
    10050984
    Address
    2052 McKenzie Drive, Building 1
    City
    Carrollton
    State
    TX
    Postal Code
    75006
    Country
    US
    Correspondent
    Kayla Chott

    Products

    Device Name Product Code
    Appliance, Fixation, Spinal Interlaminal KWP
    Appliance, Fixation, Spinal Intervertebral Body KWQ
    Orthosis, Spondylolisthesis Spinal Fixation MNH
    Orthosis, Spinal Pedicle Fixation MNI

    Proprietary Names

    Ltd Polyaxial Fixation System

    Establishment Types

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