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FDA 510(k)

LineSider® Spinal System

K-Number: K231098 · 2023-08-07

ApplicantIntegrity Implants, Inc.
Decision Date2023-08-07
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

LineSider® Spinal System is a medical device manufactured by Integrity Implants, Inc.. It received FDA 510(k) clearance on 2023-08-07 under approval number K231098. 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 LineSider® Spinal System?

LineSider® Spinal System is a medical device that received FDA 510(k) clearance on 2023-08-07. It is manufactured by Integrity Implants, Inc.. The 510(k) number is K231098.

When was LineSider® Spinal System approved by the FDA?

LineSider® Spinal System received FDA 510(k) clearance on 2023-08-07, under approval number K231098.

What company makes LineSider® Spinal System?

LineSider® Spinal System is manufactured by Integrity Implants, Inc..

What is the FDA product code for LineSider® Spinal System?

The FDA product code for LineSider® Spinal 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 Integrity Implants, Inc.

K190360LineSider™ Spinal System K183184FlareHawk Interbody Fusion System K182114FlareHawk Interbody Fusion System K203367LineSider™ Spinal System K202198FlareHawk Interbody Fusion System K201367FlareHawk TiHawk9 Interbody Fusion System

View all 11 devices →

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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