BEUDAMED
    FDA Registration Active 🇺🇸 United States

    TowerLOX Pedicle Screw System, Threshold Pedicular Fixation System, CapLOX II Pedicle Screw System

    Reg #: 3006082533 · FEI: 3006082533 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    CAPTIVA SPINE, Inc.
    Registration Number
    3006082533
    FEI Number
    3006082533
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    967 N HIGHWAY A1A ALT STE 1
    City
    Jupiter
    State
    FL
    ZIP
    33477
    Country
    US

    Regulatory Submissions

    510(k) Number
    K151116

    Owner / Operator

    Firm Name
    CAPTIVA SPINE
    Operator Number
    9096708
    Address
    967 Alternate A1A, SUITE 1
    City
    Jupiter
    State
    FL
    Postal Code
    33477
    Country
    US

    Products

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

    Proprietary Names

    TowerLOX Pedicle Screw System, Threshold Pedicular Fixation System, CapLOX II Pedicle Screw System

    Establishment Types

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