BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Tap, Cannulated, Fixed Sleeve

    Reg #: 3009165919 · FEI: 3009165919 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    18
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    Kalitec Direct LLC DBA Kalitec Medical
    Registration Number
    3009165919
    FEI Number
    3009165919
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    865 Oviedo Blvd, Suite 1017
    City
    Oviedo
    State
    FL
    ZIP
    32765
    Country
    US

    Regulatory Submissions

    510(k) Number
    K232572

    Owner / Operator

    Firm Name
    Kalitec Medical
    Operator Number
    10037099
    Address
    865 Oviedo Blvd, Suite 1017
    City
    Oviedo
    State
    FL
    Postal Code
    32765
    Country
    US

    Products

    Device Name Product Code
    Orthopedic Stereotaxic Instrument OLO
    Thoracolumbosacral Pedicle Screw System NKB
    Orthosis, Spinal Pedicle Fixation MNI

    Proprietary Names

    Tap, Cannulated, Fixed Sleeve Screwdriver, Tower Tab, SNI1 Screwdriver, Polyaxial, Standard, Fixed Tap Sleeve Screwdriver, Tower Tab, Cannulated, SNI2 Screwdriver, Extended Tab, SNI1 Tap, Cortical Cannulated, SNI1 Probe, Lenke, Straight, Fixed Sleeve Screwdriver, Polyaxial, SNI1, Lockable Awl Tap, Fixed Sleeve Tap, 4.75mm Cortical, SNI1 Kalitec Navigated Instrument System Screwdriver, Extended Tab, Cannulated, SNI1, Lockable Probe, Steffee, Straight, Fixed Sleeve Screwdriver, Modular Bone Screw, SNI1 Screwdriver, Tower Tab, Cannulated, SNI1 Screwdriver, Extended Tab, Fixed Tap Sleeve Tap, 8.5mm Cortical, SNI1 Screwdriver, Polyaxial, Cannulated, SNI1, Lockable

    Establishment Types

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