CD HORIZON® Spinal System
K-Number: K163301 · 2016-12-20
ApplicantMedtronic Sofamor Danek USA, Inc.
Decision Date2016-12-20
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
CD HORIZON® Spinal System is a medical device manufactured by Medtronic Sofamor Danek USA, Inc.. It received FDA 510(k) clearance on 2016-12-20 under approval number K163301. 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® Spinal System?
CD HORIZON® Spinal System is a medical device that received FDA 510(k) clearance on 2016-12-20. It is manufactured by Medtronic Sofamor Danek USA, Inc.. The 510(k) number is K163301.
When was CD HORIZON® Spinal System approved by the FDA?
CD HORIZON® Spinal System received FDA 510(k) clearance on 2016-12-20, under approval number K163301.
What company makes CD HORIZON® Spinal System?
CD HORIZON® Spinal System is manufactured by Medtronic Sofamor Danek USA, Inc..
What is the FDA product code for CD HORIZON® Spinal System?
The FDA product code for CD HORIZON® Spinal System is NKB.
Related Clinical Trials
NCT06998134
Toward Ubiquitous Lower Limb Exoskeleton Use in Children and Young Adults
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
NCT07308847
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
RECRUITING
Related PubMed Literature
Other Devices by Medtronic Sofamor Danek USA, Inc.
Related Devices (Code: NKB)
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.
K162576FORTEZZA Spinal Stabilization SystemOsso Surgical
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.