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)

Vulcan Spinal System

K-Number: K253545 · 2026-02-10

ApplicantK2m, Inc.
Decision Date2026-02-10
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Vulcan Spinal System is a medical device manufactured by K2m, Inc.. It received FDA 510(k) clearance on 2026-02-10 under approval number K253545. 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 Vulcan Spinal System?

Vulcan Spinal System is a medical device that received FDA 510(k) clearance on 2026-02-10. It is manufactured by K2m, Inc.. The 510(k) number is K253545.

When was Vulcan Spinal System approved by the FDA?

Vulcan Spinal System received FDA 510(k) clearance on 2026-02-10, under approval number K253545.

What company makes Vulcan Spinal System?

Vulcan Spinal System is manufactured by K2m, Inc..

What is the FDA product code for Vulcan Spinal System?

The FDA product code for Vulcan 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 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 K2m, Inc.

K162664Pyrenees Cervical Plate System K162264Cascadia Interbody System K161028K2M Growing Spine System K160208NILE Alternative Fixation Spinal System K172009Cascadia Interbody System K171832Range/Denali/Mesa Spinal System

View all 27 devices →

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.

↑