CTL Medical Corporation

FDA Device Registration & Listing · Carrollton, TX, US · Registration 3009051471

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3009051471
FEI Number
3009051471
Entity Name
CTL Medical Corporation
City/State/Country
Carrollton, TX, US
Establishment Address
2052 McKenzie Drive, Building 1, Carrollton, TX 75006, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility,Complaint File Establishment per 21 CFR 820.198
Owner / Operator
CTL Amedica (Owner Number: 10050984)
Owner / Operator Contact Address
2052 McKenzie Drive, Building 1, Carrollton, TX 75006, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K220513
PMA Number
N/A

All Registered Proprietary Names

Valeo II Interbody Fusion Devices 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 Probe 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 Valeo II Interbody Fusion Devices Phantom Plus Cage System Taurus Pedicle Screw System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2018-10-23
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2018-10-23
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2018-10-23
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2018-10-23
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2018-10-23
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2018-10-23
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2016-01-22
OUR Sacroiliac Joint Fixation Orthopedic Class 2 888.3040 2022-10-27
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2016-01-22
FZX Guide, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2016-01-22
GFA Blade, Saw, General & Plastic Surgery, Surgical General, Plastic Surgery Class 1 878.4820 2016-01-22
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2016-01-22
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2016-01-22
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2016-01-22
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2018-06-11
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2018-06-11
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2018-06-11
HWT Template Orthopedic Class 1 888.4800 2025-09-02
HWA Impactor Orthopedic Class 1 888.4540 2025-09-02
HXW Bender Orthopedic Class 1 888.4540 2025-09-02
FTY Tape, Measuring, Rulers And Calipers General, Plastic Surgery Class 1 878.4800 2016-01-22
HWB Extractor Orthopedic Class 1 888.4540 2025-09-02
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2018-10-23
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2018-10-23
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2018-10-23
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2018-10-23
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2018-10-23
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2018-10-23
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2018-10-23
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2018-10-23
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2018-10-23
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2018-10-23
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2018-10-23
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2022-10-25
HTX Rongeur Orthopedic Class 1 888.4540 2016-01-22
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2022-11-15
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2022-11-15
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2024-10-16
HXX Screwdriver Orthopedic Class 1 888.4540 2016-01-22
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2024-01-30
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2016-01-22
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2016-01-22
HTF Curette General, Plastic Surgery Class 1 878.4800 2016-01-22
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2018-10-23
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2020-10-06
HXB Probe Orthopedic Class 1 888.4540 2025-09-02
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2016-01-22
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2016-01-22
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2016-01-22
GDI Dissector, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2016-01-22
HWM Osteotome General, Plastic Surgery Class 1 878.4800 2016-01-22
FSM Tray, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2023-12-29
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2018-10-23
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2018-10-23
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2018-10-23
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2016-01-22
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2016-01-22
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2016-01-22
HXG Tamp Orthopedic Class 1 888.4540 2025-09-02
HTR Rasp General, Plastic Surgery Class 1 878.4800 2025-09-02
GCY Apparatus, Suction, Single Patient Use, Portable, Nonpowered General, Plastic Surgery Class 1 878.4680 2016-01-22
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2018-10-23
HTW Bit, Drill Orthopedic Class 1 888.4540 2025-09-02
HTD Forceps General, Plastic Surgery Class 1 878.4800 2016-01-22
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2016-01-22
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2016-01-22
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2016-01-22
GDG Hook, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2016-01-22
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2018-10-23
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2018-10-23
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2018-10-23
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2018-10-23
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2018-10-23
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2018-10-23
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2018-10-23
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2018-10-23
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2023-07-05
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2023-07-05
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2023-07-05

Official Correspondent

Kayla Chott

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

CTL Amedica
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K223430 Life Spine, Inc. ProLift Micro Expandable Spacer System 2023-05-04
K102293 Globus Medical, Inc. CALIBER SPACER 2011-01-05
K193541 Nu Vasive, Incorporated NuVasive Cohere Thoracolumbar Interbody System 2020-03-30
K080401 Advanced Medical Technologies AG SHELL CAGE, WAVE CAGE, LOOP CAGE 2008-05-09
K200084 Zavation Medical Products, LLC Zavation IBF System 2020-10-19

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0036-2013 Medtronic Sofamor Danek USA Inc 2
ATLANTIS(R) Anterior Cervical Plate System VARIABLE ANGLE SCREW MODULE, REF 176-503, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used.
Z-0037-2013 Medtronic Sofamor Danek USA Inc 2
ATLANTIS(R) Anterior Cervical Plate System FIXED ANGLE SCREW MODULE, REF 176-504, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used.
Z-0038-2013 Medtronic Sofamor Danek USA Inc 2
PREMIER(R) Anterior Cervical Plate System SCREW BLOCK, REF 1860503, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used.
Z-0040-05 Zimmer Spine, Inc. 2
ATO Drill Guide Kit (All Through One Drill Guides Set), model number 07.00860.001, product is packaged in trays.
Z-0026-2011 Zimmer Inc. 2
SpeedLink 5.5 Transverse Connector Short 39.5-44mm, non-sterile, 1302-55S

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009051471. Last updated year: 2026. Please use registration number 3009051471 when referencing this establishment in official correspondence.
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