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FDA 510(k)

GII Spinal Fixation System

K-Number: K210306 · 2021-05-19

ApplicantColigne AG
Decision Date2021-05-19
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

GII Spinal Fixation System is a medical device manufactured by Coligne AG. It received FDA 510(k) clearance on 2021-05-19 under approval number K210306. 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 GII Spinal Fixation System?

GII Spinal Fixation System is a medical device that received FDA 510(k) clearance on 2021-05-19. It is manufactured by Coligne AG. The 510(k) number is K210306.

When was GII Spinal Fixation System approved by the FDA?

GII Spinal Fixation System received FDA 510(k) clearance on 2021-05-19, under approval number K210306.

What company makes GII Spinal Fixation System?

GII Spinal Fixation System is manufactured by Coligne AG.

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

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

Related Clinical Trials

NCT06998134 Toward Ubiquitous Lower Limb Exoskeleton Use in Children and Young Adults RECRUITING NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT03053791 Deep Brain Stimulation in Patients With Incomplete Spinal Cord Injury for Improvement of Gait RECRUITING NCT07616050 Evaluation of the Impact of Virtual Park on Training Motivation in Adult Patients NOT_YET_RECRUITING NCT07277946 AtraUmatic Laparoscopic HerNia Repair Clinical Investigation to Evaluate the Safety and Performance of The ECLIPSIUM System for Mesh Fixation IDE RECRUITING NCT05508360 "Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2) RECRUITING

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 Coligne AG

K173148ACIF K181963ostaPek Interbody Fusion Cages K173893Trabis

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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