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FDA 510(k)

Spinal Inner Fixation System

K-Number: K222031 · 2022-10-28

ApplicantChangzhou Geasure Medical Apparatus and Instruments Co., Ltd.
Decision Date2022-10-28
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Spinal Inner Fixation System is a medical device manufactured by Changzhou Geasure Medical Apparatus and Instruments Co., Ltd.. It received FDA 510(k) clearance on 2022-10-28 under approval number K222031. 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 Spinal Inner Fixation System?

Spinal Inner Fixation System is a medical device that received FDA 510(k) clearance on 2022-10-28. It is manufactured by Changzhou Geasure Medical Apparatus and Instruments Co., Ltd.. The 510(k) number is K222031.

When was Spinal Inner Fixation System approved by the FDA?

Spinal Inner Fixation System received FDA 510(k) clearance on 2022-10-28, under approval number K222031.

What company makes Spinal Inner Fixation System?

Spinal Inner Fixation System is manufactured by Changzhou Geasure Medical Apparatus and Instruments Co., Ltd..

What is the FDA product code for Spinal Inner Fixation System?

The FDA product code for Spinal Inner Fixation System is NKB.

Related Clinical Trials

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Related PubMed Literature

PMID: 41612341 Brain-computer interface commercialization. Journal of neuroengineering and rehabilitation (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 Changzhou Geasure Medical Apparatus and Instruments Co., Ltd.

K232394Internal Locking Plate and Screw Fixation System K230456SGM Femoral Nail System K223776PEEK Spinal Infusion Cage

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

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