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FDA 510(k)

4CIS Chiron Spinal Fixation System

K-Number: K203233 · 2022-06-01

ApplicantSolco Biomedical Co., Ltd.
Decision Date2022-06-01
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

4CIS Chiron Spinal Fixation System is a medical device manufactured by Solco Biomedical Co., Ltd.. It received FDA 510(k) clearance on 2022-06-01 under approval number K203233. 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 4CIS Chiron Spinal Fixation System?

4CIS Chiron Spinal Fixation System is a medical device that received FDA 510(k) clearance on 2022-06-01. It is manufactured by Solco Biomedical Co., Ltd.. The 510(k) number is K203233.

When was 4CIS Chiron Spinal Fixation System approved by the FDA?

4CIS Chiron Spinal Fixation System received FDA 510(k) clearance on 2022-06-01, under approval number K203233.

What company makes 4CIS Chiron Spinal Fixation System?

4CIS Chiron Spinal Fixation System is manufactured by Solco Biomedical Co., Ltd..

What is the FDA product code for 4CIS Chiron Spinal Fixation System?

The FDA product code for 4CIS Chiron Spinal 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 Solco Biomedical Co., Ltd.

K1624024CIS® Marlin ACIF Cage System K1920444CIS Marlin PEEK ACIF Cage K1905634CIS PEEK PLIF Cage, 4CIS Pebble Beach PEEK PLIF Cage, 4CIS Torrey Pines PEEK TLIF Cage, 4CIS Dunes PEEK DLIF Cage, 4CIS Augusta PEEK ALIF Cage K1904714CIS® Chiron Spinal Fixation System K1824894CIS® Pinehurst Anterior Cervical Plate system K2316554CIS® Chiron Spinal Fixation System

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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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