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FDA 510(k)

Dark Star Deformity Pedicle Screw System

K-Number: K223096 · 2023-05-26

ApplicantRepublic Spine, LLC
Decision Date2023-05-26
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Dark Star Deformity Pedicle Screw System is a medical device manufactured by Republic Spine, LLC. It received FDA 510(k) clearance on 2023-05-26 under approval number K223096. 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 Dark Star Deformity Pedicle Screw System?

Dark Star Deformity Pedicle Screw System is a medical device that received FDA 510(k) clearance on 2023-05-26. It is manufactured by Republic Spine, LLC. The 510(k) number is K223096.

When was Dark Star Deformity Pedicle Screw System approved by the FDA?

Dark Star Deformity Pedicle Screw System received FDA 510(k) clearance on 2023-05-26, under approval number K223096.

What company makes Dark Star Deformity Pedicle Screw System?

Dark Star Deformity Pedicle Screw System is manufactured by Republic Spine, LLC.

What is the FDA product code for Dark Star Deformity Pedicle Screw System?

The FDA product code for Dark Star Deformity Pedicle Screw System is NKB.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT07598604 Early Mobilization and Equinus Correction in Spastic Cerebral Palsy NOT_YET_RECRUITING NCT07589829 The Effects of Kinesio Taping on Hallux Valgus COMPLETED NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION NCT05565131 Performance Measurement and Safety Evaluation of the PYTHEAS® ODYSSEE Angular Assistance System for Intra-pedicular Screw Placement in Adult Spine Surgery COMPLETED NCT06720948 The ION Facet Screw System Ambispective Evaluation ENROLLING_BY_INVITATION

Related PubMed Literature

PMID: 41487949 Verification, validation, and uncertainty quantification of finite element analysis results for pedicle screw assemblies under ASTM F1717 flexion and extension testing. Frontiers in bioengineering and biotechnology (2025)

Other Devices by Republic Spine, LLC

K181495Republic Spine Dark Star Spinal System 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

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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