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FDA 510(k)

COLONNADE Posterior Screw Fixation System

K-Number: K250582 · 2025-05-08

ApplicantCG Bio Co., Ltd.
Decision Date2025-05-08
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

COLONNADE Posterior Screw Fixation System is a medical device manufactured by CG Bio Co., Ltd.. It received FDA 510(k) clearance on 2025-05-08 under approval number K250582. 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 COLONNADE Posterior Screw Fixation System?

COLONNADE Posterior Screw Fixation System is a medical device that received FDA 510(k) clearance on 2025-05-08. It is manufactured by CG Bio Co., Ltd.. The 510(k) number is K250582.

When was COLONNADE Posterior Screw Fixation System approved by the FDA?

COLONNADE Posterior Screw Fixation System received FDA 510(k) clearance on 2025-05-08, under approval number K250582.

What company makes COLONNADE Posterior Screw Fixation System?

COLONNADE Posterior Screw Fixation System is manufactured by CG Bio Co., Ltd..

What is the FDA product code for COLONNADE Posterior Screw Fixation System?

The FDA product code for COLONNADE Posterior Screw Fixation System is NKB.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT05391828 Persona MC vs PS RCT With ROSA RECRUITING NCT07277946 AtraUmatic Laparoscopic HerNia Repair Clinical Investigation to Evaluate the Safety and Performance of The ECLIPSIUM System for Mesh Fixation IDE RECRUITING NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION NCT07527299 A Study of VARIPULSE Catheter in Participants With Persistent Atrial Fibrillation Undergoing Pulmonary Vein and Superior Vena Cava Isolation NOT_YET_RECRUITING NCT02839850 14022 ATTUNE Cementless RP Clinical Performance Evaluation ACTIVE_NOT_RECRUITING

Other Devices by CG Bio Co., Ltd.

K160731LumFix Spinal Fixation Sytem K222229Advanced LumFix Spinal Fixation System K252251EASYMADE-TI

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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