BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Kalitec Direct LLC DBA Kalitec Medical

    Reg #: 3009165919 · FEI: 3009165919 · Expires 2026
    View on FDA
    Products
    41
    Proprietary Names
    67
    Establishment Types
    3
    Classifications
    41

    Registration Details

    Registration Name
    Kalitec Direct LLC DBA Kalitec Medical
    Registration Number
    3009165919
    FEI Number
    3009165919
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1819 Main St Ste 303
    City
    Sarasota
    State
    FL
    ZIP
    34236
    Country
    US

    Regulatory Submissions

    510(k) Number
    K123100

    Owner / Operator

    Firm Name
    Kalitec Medical
    Operator Number
    10037099
    Address
    1819 Main St, Suite 303
    City
    Sarasota
    State
    FL
    Postal Code
    34236
    Country
    US

    Products

    Device Name Product Code
    Caliper KTZ
    Instrument, Cutting, Orthopedic HTZ
    Bender HXW
    Intervertebral Fusion Device With Bone Graft, Lumbar MAX
    Impactor HWA
    Instrument, Compression HWN
    Extractor HWB
    Rasp HTR
    Orthosis, Spondylolisthesis Spinal Fixation MNH
    Orthosis, Spinal Pedicle Fixation MNI
    Template HWT
    Bit, Drill HTW
    Wrench HXC
    Orthopedic Stereotaxic Instrument OLO
    Thoracolumbosacral Pedicle Screw System NKB
    Retainer, Surgical GCZ
    Starter, Bone Screw HWD
    Awl HWJ
    Guide, Needle, Surgical GDF
    Hammer, Surgical FZY
    Spinous Process Plate PEK
    Tamp HXG
    Appliance, Fixation, Spinal Intervertebral Body KWQ
    Screwdriver HXX
    Tap, Bone HWX
    Rongeur HTX
    Tray, Surgical, Instrument FSM
    Driver, Prosthesis HWR
    Pliers, Surgical HTC
    Dissector, Surgical, General & Plastic Surgery GDI
    Tray, Surgical LRP
    Rasp, Surgical, General & Plastic Surgery GAC
    Orthopedic Manual Surgical Instrument LXH
    Cannula, Surgical, General & Plastic Surgery GEA
    Passer, Wire, Orthopedic HXI
    Probe HXB
    Holder, Needle; Orthopedic HXK
    Curette HTF
    Guide, Surgical, Instrument FZX
    Intervertebral Fusion Device With Bone Graft, Cervical ODP
    Punch, Surgical LRY

    Proprietary Names

    NIDO Decorticating Planer NIDO Sagittal Bender, Dbl Ended Left NIDO Sagittal Bender, Dbl Ended Right Awl Tap, Fixed Sleeve Screwdriver, Extended Tab, SNI1 Screwdriver, Tower Tab, Cannulated, SNI2 Screwdriver, Tower Tab, SNI1 Tap, Cannulated, Fixed Sleeve Screwdriver, Tower Tab, Cannulated, SNI1 Tap, Cortical Cannulated, SNI1 Screwdriver, Polyaxial, Standard, Fixed Tap Sleeve Tap, 8.5mm Cortical, SNI1 Kalitec Navigated Instrument System Probe, Lenke, Straight, Fixed Sleeve Screwdriver, Polyaxial, Cannulated, SNI1, Lockable Screwdriver, Extended Tab, Cannulated, SNI1, Lockable Probe, Steffee, Straight, Fixed Sleeve Screwdriver, Modular Bone Screw, SNI1 Screwdriver, Extended Tab, Fixed Tap Sleeve Tap, 4.75mm Cortical, SNI1 Screwdriver, Polyaxial, SNI1, Lockable NIDO T-Handle, T20 Dominoes Cap Starter NIDO T-Handle, T30 Split Tip Cap Starter InSePtion MIS Fixation System NIDO Pedicle Screw System CosmoLock Pedicle Screw System Matira Anterior Cervical System Ocata Anterior Cervical System NIDO Screwdriver, Modular Bone Screws Screwdriver, NIDO Assembled Screws Screwdriver, NIDO Assembled Screws, Sleeved NIDO Screwdriver, Assem Screws SNI1 Kalitec Disc Prep 3 mm Up Biting Pituitary Kalitec Disc Prep 3 mm Straight Pituitary NIDO Inserter, Dominoes NIDO Inserter, Tulips and Connectors Navagio Lumbar Cage System NIDO Caddie, Modular Heads, Polyaxial NIDO Caddie, Domino Connectors NIDO Tray Insert 2 (FROM COSMO) NIDO Tray, 2" Base NIDO Rod Connector Tray Insert 1 NIDO Tray Insert 3 NIDO Tray Insert 1 NIDO Caddie Lid, Tulip and Domino Connectors NIDO Caddie,Locking Caps NIDO Caddie Lid, Modular Heads, Polyaxial NIDO Implant Tray 1, Degen NIDO Caddie, Locking Caps NIDO Tray, 4.25" Base NIDO Caddie, Tulip Connectors NIDO Caddie,Modular Bone Screws NIDO Caddie Lid, Modular Bone Screws NIDO Tray Insert 4 NIDO Rocker, Hinged Locking NIDO Counter Torque, Dominoes NIDO Counter Torque, Std & Ext Tab NIDO Driver Shaft, T30 Final Cap Driver NIDO Driver Shaft, T20 Final Domino Cap Driver NIDO Rod Reducer, Axial, NIDO NIDO T-Handle, Head Persuader NIDO Rocker, One Piece NIDO Tap, 5.50mm NIDO Tap, 4.75mm NIDO Tap, 7.50mm NIDO Tap, 6.50mm Inseption MIS Fixation System

    Establishment Types

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