FDA 510(k)

VyLink Spinal Screw System

K-Number: K231744 · 2023-10-13

Decision Date2023-10-13

Product CodeNKB

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

VyLink Spinal Screw System is a medical device manufactured by Vy Spine, LLC. It received FDA 510(k) clearance on 2023-10-13 under approval number K231744. 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 VyLink Spinal Screw System?

VyLink Spinal Screw System is a medical device that received FDA 510(k) clearance on 2023-10-13. It is manufactured by Vy Spine, LLC. The 510(k) number is K231744.

When was VyLink Spinal Screw System approved by the FDA?

VyLink Spinal Screw System received FDA 510(k) clearance on 2023-10-13, under approval number K231744.

What company makes VyLink Spinal Screw System?

VyLink Spinal Screw System is manufactured by Vy Spine, LLC.

What is the FDA product code for VyLink Spinal Screw System?

The FDA product code for VyLink Spinal Screw 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 Vy Spine, LLC

K213219Vy Spine VyWasher Buttress System K212715Vy Spine ClariVy Cervical IBF System K213394Vy Spine VySpan PCT System K221162UniVy OsteoVy Cervical IBF System K221572VyPlate Anterior Cervical Plate System K213750VyLink Spinal Screw 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.