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FDA 510(k)

Genesys Spine TiLock Cortical Spinal System

K-Number: K161914 · 2016-08-09

ApplicantGenesys Spine
Decision Date2016-08-09
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Genesys Spine TiLock Cortical Spinal System is a medical device manufactured by Genesys Spine. It received FDA 510(k) clearance on 2016-08-09 under approval number K161914. 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 Genesys Spine TiLock Cortical Spinal System?

Genesys Spine TiLock Cortical Spinal System is a medical device that received FDA 510(k) clearance on 2016-08-09. It is manufactured by Genesys Spine. The 510(k) number is K161914.

When was Genesys Spine TiLock Cortical Spinal System approved by the FDA?

Genesys Spine TiLock Cortical Spinal System received FDA 510(k) clearance on 2016-08-09, under approval number K161914.

What company makes Genesys Spine TiLock Cortical Spinal System?

Genesys Spine TiLock Cortical Spinal System is manufactured by Genesys Spine.

What is the FDA product code for Genesys Spine TiLock Cortical Spinal System?

The FDA product code for Genesys Spine TiLock Cortical Spinal System is NKB.

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Related PubMed Literature

PMID: 39973146 Characterization of Spine Implant Device Recalls: A 21-Year Analysis. Spine (2026) PMID: 37504879 Comparative Evaluation of Mineralized Bone Allografts for Spinal Fusion Surgery. Journal of functional biomaterials (2023) PMID: 36074993 Reported Events Associated With Spine Robots: An Analysis of the Food and Drug Administration's Manufacturer and User Facility Device Experience Database. Global spine journal (2023) PMID: 35685299 Multicenter, Double-Blinded, Randomized, Active-Sham Controlled Clinical Study Design to Assess the Safety and Effectiveness of a Novel High Frequency Electric Nerve Block System in the Treatment of Post-Amputation Pain (The QUEST Study). Journal of pain research (2022)

Other Devices by Genesys Spine

K161438Genesys Spine Apache® Anterior Lumbar Interbody Fusion System K152099Genesys Spine Apache® Anchored Cervical Interbody Fusion System K161404Genesys Spine Apache® Lateral Lumbar Interbody Fusion System K153123Genesys Spine Apache Interbody Fusion System K172469TiLock Modular Spinal System K171838TiLock2 Spinal System

View all 21 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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