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FDA 510(k)

Advanced LumFix Spinal Fixation System

K-Number: K222229 · 2023-05-25

ApplicantCG Bio Co., Ltd.
Decision Date2023-05-25
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Advanced LumFix Spinal Fixation System is a medical device manufactured by CG Bio Co., Ltd.. It received FDA 510(k) clearance on 2023-05-25 under approval number K222229. 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 Advanced LumFix Spinal Fixation System?

Advanced LumFix Spinal Fixation System is a medical device that received FDA 510(k) clearance on 2023-05-25. It is manufactured by CG Bio Co., Ltd.. The 510(k) number is K222229.

When was Advanced LumFix Spinal Fixation System approved by the FDA?

Advanced LumFix Spinal Fixation System received FDA 510(k) clearance on 2023-05-25, under approval number K222229.

What company makes Advanced LumFix Spinal Fixation System?

Advanced LumFix Spinal Fixation System is manufactured by CG Bio Co., Ltd..

What is the FDA product code for Advanced LumFix Spinal Fixation System?

The FDA product code for Advanced LumFix Spinal Fixation System is NKB.

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Related PubMed Literature

PMID: 41612341 Brain-computer interface commercialization. Journal of neuroengineering and rehabilitation (2026) PMID: 40003250 Bridging the Gap in FDA Approval for Pediatric Neuromodulation Devices. Children (Basel, Switzerland) (2025) PMID: 39726899 How to improve the mechanical safety of a novel spinal implant while saving costs and time. JOR spine (2024)

Other Devices by CG Bio Co., Ltd.

K160731LumFix Spinal Fixation Sytem K250582COLONNADE Posterior Screw Fixation System K252251EASYMADE-TI

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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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