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FDA 510(k)

Mercury® Spinal System, Overwatch® Spinal System

K-Number: K191576 · 2019-09-16

ApplicantSpinal Elements, Inc.
Decision Date2019-09-16
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Mercury® Spinal System, Overwatch® Spinal System is a medical device manufactured by Spinal Elements, Inc.. It received FDA 510(k) clearance on 2019-09-16 under approval number K191576. 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, Overwatch® Spinal System?

Mercury® Spinal System, Overwatch® Spinal System is a medical device that received FDA 510(k) clearance on 2019-09-16. It is manufactured by Spinal Elements, Inc.. The 510(k) number is K191576.

When was Mercury® Spinal System, Overwatch® Spinal System approved by the FDA?

Mercury® Spinal System, Overwatch® Spinal System received FDA 510(k) clearance on 2019-09-16, under approval number K191576.

What company makes Mercury® Spinal System, Overwatch® Spinal System?

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

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

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

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Related PubMed Literature

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 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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