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FDA 510(k)

Mercury® Spinal System

K-Number: K172967 · 2018-04-10

ApplicantSpinal Elements, Inc.
Decision Date2018-04-10
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Mercury® Spinal System is a medical device manufactured by Spinal Elements, Inc.. It received FDA 510(k) clearance on 2018-04-10 under approval number K172967. 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 Mercury® Spinal System?

Mercury® Spinal System is a medical device that received FDA 510(k) clearance on 2018-04-10. It is manufactured by Spinal Elements, Inc.. The 510(k) number is K172967.

When was Mercury® Spinal System approved by the FDA?

Mercury® Spinal System received FDA 510(k) clearance on 2018-04-10, under approval number K172967.

What company makes Mercury® Spinal System?

Mercury® Spinal System is manufactured by Spinal Elements, Inc..

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

The FDA product code for Mercury® Spinal System is NKB.

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Related PubMed Literature

PMID: 41612341 Brain-computer interface commercialization. Journal of neuroengineering and rehabilitation (2026) PMID: 39892748 Long-term Safety and Performance of a Suprachoroidal Pressure Sensor System: Results of the EYEMATE-SC Trial Follow-up Study. Ophthalmology (2025) PMID: 39726899 How to improve the mechanical safety of a novel spinal implant while saving costs and time. JOR spine (2024)

Other Devices by Spinal Elements, Inc.

K153352Vertu® & Vertu® Ti-Bond and Crystal® & Crystal® Ti-Bond Cervical Interbody System K160465Spinal Elements' Spinous Process Plate System K152011Lucent Intervertebral Body Fusion Device K170235Lucent® K182584Lucent® XP K181837Spinal Elements Ti-Bond coated devices

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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.

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