BEUDAMED
    FDA Registration Active 🇺🇸 United States

    CTL Medical Corporation

    Reg #: 3009051471 · FEI: 3009051471 · Expires 2026
    View on FDA
    Products
    42
    Proprietary Names
    149
    Establishment Types
    4
    Classifications
    42

    Registration Details

    Registration Name
    CTL Medical Corporation
    Registration Number
    3009051471
    FEI Number
    3009051471
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    2052 McKenzie Drive, Building 1
    City
    Carrollton
    State
    TX
    ZIP
    75006
    Country
    US

    Regulatory Submissions

    510(k) Number
    K161405

    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
    Intervertebral Fusion Device With Bone Graft, Lumbar MAX
    Intervertebral Fusion Device With Bone Graft, Cervical ODP
    Appliance, Fixation, Spinal Intervertebral Body KWQ
    Sacroiliac Joint Fixation OUR
    Guide, Surgical, Instrument FZX
    Blade, Saw, General & Plastic Surgery, Surgical GFA
    Orthosis, Spinal Pedicle Fixation MNI
    Appliance, Fixation, Spinal Interlaminal KWP
    Thoracolumbosacral Pedicle Screw System NKB
    Template HWT
    Impactor HWA
    Bender HXW
    Tape, Measuring, Rulers And Calipers FTY
    Extractor HWB
    Orthosis, Spondylolisthesis Spinal Fixation MNH
    Orthopedic Stereotaxic Instrument OLO
    Rongeur HTX
    Intervertebral Fusion Device With Integrated Fixation, Lumbar OVD
    Screwdriver HXX
    Orthopedic Manual Surgical Instrument LXH
    Curette HTF
    Probe HXB
    Dissector, Surgical, General & Plastic Surgery GDI
    Osteotome HWM
    Tray, Surgical, Instrument FSM
    Intervertebral Fusion Device With Integrated Fixation, Cervical OVE
    Tamp HXG
    Rasp HTR
    Apparatus, Suction, Single Patient Use, Portable, Nonpowered GCY
    Spinal Vertebral Body Replacement Device MQP
    Bit, Drill HTW
    Forceps HTD
    Hook, Surgical, General & Plastic Surgery GDG
    Awl HWJ
    Handle, Scalpel GDZ
    Elevator HTE
    Table And Attachments, Operating-Room BWN
    Wrench HXC
    Instrument, Compression HWN
    Retractor GAD
    Mallet HXL
    Tap, Bone HWX

    Proprietary Names

    Valeo II Interbody Fusion Devices Valeo Spacer and Valeo II Interbody Fusion Devices Cassatt CEZANNE II Interbody Fusion System Drill Guide Knife Handle, Vertical VAN GOGH Anterior Cervical Plate System RENOIR Posterior Cervical Fixation System Seurat Universal Pedicle Screw System Template Impactor Bender Caliper Extractor Preference Pedicle Screw System Valeo Spacer System DALI Spinal Fixation System Universal Pilot Guidance Instrument System Micro-Pituitary Rongeur, Pituitary Rongeur, Kerrison Rongeur Mondrian Alif Cage With Supplementary Fixation Plate KLIMT Expandable Lumbar Interbody Fusion (LIF) Cage System Screw Driver MONDRIAN Anterior Lumbar Plate System Rod Pusher Compressor Torque Limiting Handle Rod Persuader K-Wire K-Wire Holder Adjustable Stopper; Plate Bender; Hex Driver; Tap; Screw Remover; Temporary fixation pin; Temporary Fixation Pin driver Driver, Set Screw, Star Guide Pin ACIF Cage Holder Rod Rocker Arm Driver, Reduction Screw Tester Paddle Disc Shaver Holder, Cross Connector Rescue Driver Cutter, Pin Adaptor, QC, 1/4" Square Female to Tri-Flat Male Counter Torque, Cross Connector Disc Elevator TLIF Cage Inserter, Bullet Tip Rod Inserter Distractor Drill Bit Derotation Sleeve Coupler Pituitary Kerrison Rongeur Cutter, Sleeve T-Handle, Ratcheting ACIF Rasp Rod Cutter Derotation Sleeve Reduction Driver Slap Hammer Driver, Torque Limiter Anti-Torque Device Plate Holder Probe Drill, Cannulated Derotation Sleeve, Long Hex Socket Driver Screw Extractor Drill, Trilobe End TLIF Cage Graft Packing Block ACIF Trial Driver, Screw Rod Bender Driver, Polyaxial Screw Locking Plate Driver Shaft Rod Holding Forceps Alignment Tool Reduction Screwhead Cutter ACIF Cage Impactor Small Ring Curette Venus Basic Implant Container Rocker Hook Impactor Plate-Cage Assembly Block AO Coupling T-handle Cutter Retractor Modular Instrument Holder Alignment Guide 4 Hex Screw Cannula Driver In-Line Torquelimiting Set Screw Driver Torque Wrench Set Screw Driver Guide Spreader Rod Fork Link Quick Driver Venus Basic Instrument Cover Screw Adjuster ACIF cage graft holder Coronal Bender [Right/Left] Venus Basic Implant Leg - (standard, emergency, accessory) Modula T-handle Removal Quick Driver Angled Hook Holder Venus Basic Implant Cover Cannula Tap Derotator Device Set Screw Driver Adaptor Housing Introducer Derotator In-Line Torquelimiting Link Screw Driver 4 Hex, 5 Hex Drivers 1/4" square ratchet handle Venus Basic Instrument Container Rod Holder / Rod Holder Middle / Power Holder Hook Holder DTS Guide Inserter Driver 3 Hex Ball Tester - straight,curved CEZANNE Lumbar Interbody Fusion Cage System Curette, Bayonet Shaft Valeo C+CSC with Lumen IBFD System MONDRIAN Lumbar Interbody Fusion Cage System RAPHAEL Pedicle Screw System Dissector Osteotome Instrument and Implant Cases, Trays, and Modules MONET Anterior Cervical Interbody Fusion Cage System with Supplementary Fixation Plate MONET Anterior Cervical Interbody Fusion Cage System PICASSO MIS Spinal System Tamp Rasp Suction Tube Valeo VBR Drill Forceps PICASSO II MIS Spinal System Hook Phantom Plus Cage System Taurus Pedicle Screw System MATISSE Anterior Cervical Interbody Fusion Cage System Awl Mtisse Anterior Cervical Interbody Fusion Cage System Knife Handle Table and Accessories Wrench Parallel Compressor & Distractor Preference II Pedicle Screw System MIS Retractor Tube Mallet TAP Matisse Anterior Cervical Interbody Fusion Cage System, Ti-PEEK Monet Anterior Cervical Plate System

    Establishment Types

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