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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 the device name listed in this FDA 510(k) record. The listed applicant is CG Bio Co., Ltd.. It received FDA 510(k) clearance on 2025-05-08 under 510(k) 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. The listed applicant is CG Bio Co., Ltd.. The 510(k) number is K250582.

When did COLONNADE Posterior Screw Fixation System receive FDA 510(k) clearance?

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

Who is the listed applicant for COLONNADE Posterior Screw Fixation System?

The FDA 510(k) record lists CG Bio Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07222787Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion OutcomesRECRUITING

Other records listing CG Bio Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253199CURASYS 2 (EMDN0003)K252251EASYMADE-TIK222229Advanced LumFix Spinal Fixation SystemK160731LumFix Spinal Fixation Sytem

Related Devices (Code: NKB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260362QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration)MANTIZ Co., Ltd.K253943Tiger 2 SystemZavation Medical Products, LLCK261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.OK253045“Socko” Vimax Spinal Fixation SystemSocko Medical Co., Ltd.K251251ChanPin Pedicle Screw Spinal SystemChanpin Medtak Co., Ltd.

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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