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FDA 510(k)

Universal Spinal System

K-Number: K252729 · 2025-11-18

ApplicantDouble Medical Technology, Inc.
Decision Date2025-11-18
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Universal Spinal System is a medical device manufactured by Double Medical Technology, Inc.. It received FDA 510(k) clearance on 2025-11-18 under approval number K252729. 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 Universal Spinal System?

Universal Spinal System is a medical device that received FDA 510(k) clearance on 2025-11-18. It is manufactured by Double Medical Technology, Inc.. The 510(k) number is K252729.

When was Universal Spinal System approved by the FDA?

Universal Spinal System received FDA 510(k) clearance on 2025-11-18, under approval number K252729.

What company makes Universal Spinal System?

Universal Spinal System is manufactured by Double Medical Technology, Inc..

What is the FDA product code for Universal Spinal System?

The FDA product code for Universal 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 NCT07608939 Postoperative Pain After Root Canal Treatment Using Different Root Canal Sealers 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: 39726899 How to improve the mechanical safety of a novel spinal implant while saving costs and time. JOR spine (2024)

Other Devices by Double Medical Technology, Inc.

K151458Double Medical Universal Spine System K172830Double Medical Femoral Nail System K172828Double Medical Cage System K221221Advanced Intramedullary Nail System K220921Metal Bone Screw K233078Posterior Cervical Spine System

View all 12 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.

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