FDA 510(k)

LineSider Spinal System

K-Number: K203367 · 2020-12-03

Decision Date2020-12-03

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 2020-12-03 under approval number K203367. 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 2020-12-03. It is manufactured by Integrity Implants, Inc.. The 510(k) number is K203367.

When was LineSider Spinal System approved by the FDA?

LineSider Spinal System received FDA 510(k) clearance on 2020-12-03, under approval number K203367.

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.

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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 K202198FlareHawk Interbody Fusion System K201367FlareHawk TiHawk9 Interbody Fusion System K212088Integrity Implants Navigated Instruments

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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.