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FDA 510(k)

Republic Spine Dark Star Spinal System

K-Number: K181495 · 2018-07-25

ApplicantRepublic Spine, LLC
Decision Date2018-07-25
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Republic Spine Dark Star Spinal System is a medical device manufactured by Republic Spine, LLC. It received FDA 510(k) clearance on 2018-07-25 under approval number K181495. 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 Republic Spine Dark Star Spinal System?

Republic Spine Dark Star Spinal System is a medical device that received FDA 510(k) clearance on 2018-07-25. It is manufactured by Republic Spine, LLC. The 510(k) number is K181495.

When was Republic Spine Dark Star Spinal System approved by the FDA?

Republic Spine Dark Star Spinal System received FDA 510(k) clearance on 2018-07-25, under approval number K181495.

What company makes Republic Spine Dark Star Spinal System?

Republic Spine Dark Star Spinal System is manufactured by Republic Spine, LLC.

What is the FDA product code for Republic Spine Dark Star Spinal System?

The FDA product code for Republic Spine Dark Star 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: 41987831 From Concept to Clinic: Pre-Clinical Testing and Regulatory Considerations in Spine Implant Development. JOR spine (2026) PMID: 41612341 Brain-computer interface commercialization. Journal of neuroengineering and rehabilitation (2026) PMID: 39973146 Characterization of Spine Implant Device Recalls: A 21-Year Analysis. Spine (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 Republic Spine, LLC

K190398Republic Spine Restore Intervertebral Body Fusion System K190889Republic Spine Restore Cervical Interbody Fusion System K212028Dark Star Navigation Instrument System K201420Republic Spine Dark Star Spinal System K223096Dark Star Deformity Pedicle Screw System

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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