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FDA 510(k)

CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)

K-Number: K233951 · 2024-03-27

ApplicantMedtronic Sofamor Danek USA, Inc.
Decision Date2024-03-27
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw) is a medical device manufactured by Medtronic Sofamor Danek USA, Inc.. It received FDA 510(k) clearance on 2024-03-27 under approval number K233951. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)?

CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw) is a medical device that received FDA 510(k) clearance on 2024-03-27. It is manufactured by Medtronic Sofamor Danek USA, Inc.. The 510(k) number is K233951.

When was CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw) approved by the FDA?

CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw) received FDA 510(k) clearance on 2024-03-27, under approval number K233951.

What company makes CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)?

CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw) is manufactured by Medtronic Sofamor Danek USA, Inc..

What is the FDA product code for CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)?

The FDA product code for CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw) is NKB.

Related Clinical Trials

NCT06998134 Toward Ubiquitous Lower Limb Exoskeleton Use in Children and Young Adults RECRUITING NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT03053791 Deep Brain Stimulation in Patients With Incomplete Spinal Cord Injury for Improvement of Gait RECRUITING NCT07616050 Evaluation of the Impact of Virtual Park on Training Motivation in Adult Patients NOT_YET_RECRUITING NCT05508360 "Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2) RECRUITING NCT06087445 A User-friendly, Non-invasive Neuro-orthosis That Restores Volitionally Controlled Grasp Functions for SCI Survivors With Tetraplegia COMPLETED

Related PubMed Literature

PMID: 41612341 Brain-computer interface commercialization. Journal of neuroengineering and rehabilitation (2026) PMID: 41487949 Verification, validation, and uncertainty quantification of finite element analysis results for pedicle screw assemblies under ASTM F1717 flexion and extension testing. Frontiers in bioengineering and biotechnology (2025) PMID: 39726899 How to improve the mechanical safety of a novel spinal implant while saving costs and time. JOR spine (2024)

Other Devices by Medtronic Sofamor Danek USA, Inc.

K163301CD HORIZON® Spinal System K162680SOVEREIGN® Spinal System K162379CD HORIZON® Spinal System K162494CD HORIZON® Spinal System K160528ANATOMIC PEEK PTC Cervical Fusion System K160418PERIMETER Interbody Fusion Device

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Related Devices (Code: NKB)

K163301CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc. K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC K162912VIPER PRIME™ additions to the VIPER® SystemMedos International SARL K162160Preference Elite Pedicle Screw SystemAmedica Corporation K162232MOSS 100 Pedicle Screw SystemBiedermann Motech GmbH & Co. KG K162379CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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