Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SOVEREIGN® Spinal System

K-Number: K162680 · 2016-12-14

ApplicantMedtronic Sofamor Danek USA, Inc.
Decision Date2016-12-14
Product CodeOVD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SOVEREIGN® Spinal System is a medical device manufactured by Medtronic Sofamor Danek USA, Inc.. It received FDA 510(k) clearance on 2016-12-14 under approval number K162680. The device is classified under product code OVD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOVEREIGN® Spinal System?

SOVEREIGN® Spinal System is a medical device that received FDA 510(k) clearance on 2016-12-14. It is manufactured by Medtronic Sofamor Danek USA, Inc.. The 510(k) number is K162680.

When was SOVEREIGN® Spinal System approved by the FDA?

SOVEREIGN® Spinal System received FDA 510(k) clearance on 2016-12-14, under approval number K162680.

What company makes SOVEREIGN® Spinal System?

SOVEREIGN® Spinal System is manufactured by Medtronic Sofamor Danek USA, Inc..

What is the FDA product code for SOVEREIGN® Spinal System?

The FDA product code for SOVEREIGN® Spinal System is OVD.

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 NCT07603258 Access-H20: Sensor-driven Smart Faucet Related Study COMPLETED

Related PubMed Literature

PMID: 41612341 Brain-computer interface commercialization. Journal of neuroengineering and rehabilitation (2026) 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 K162379CD HORIZON® Spinal System K162494CD HORIZON® Spinal System K160528ANATOMIC PEEK PTC Cervical Fusion System K160418PERIMETER Interbody Fusion Device K153438PERIMETER C (Titanium) Spinal System

View all 76 devices →

Related Devices (Code: OVD)

K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation K161993Leva® Anterior Interbody SystemSpine Wave, Inc. K161379ELSA SpacersGlobus Medical, Inc. K161173Avenue® T TLIF CageLdr Spine USA, Inc. K161129PILLAR SA PTCOrthofix, Inc. K160597INDEPENDENCE MIS SpacersGlobus Medical, 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.

↑