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FDA 510(k)

NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR System

K-Number: K193506 · 2020-02-26

ApplicantNu Vasive, Incorporated
Decision Date2020-02-26
Product CodeMQP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR System is a medical device manufactured by Nu Vasive, Incorporated. It received FDA 510(k) clearance on 2020-02-26 under approval number K193506. The device is classified under product code MQP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR System?

NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR System is a medical device that received FDA 510(k) clearance on 2020-02-26. It is manufactured by Nu Vasive, Incorporated. The 510(k) number is K193506.

When was NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR System approved by the FDA?

NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR System received FDA 510(k) clearance on 2020-02-26, under approval number K193506.

What company makes NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR System?

NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR System is manufactured by Nu Vasive, Incorporated.

What is the FDA product code for NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR System?

The FDA product code for NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR System is MQP.

Related Clinical Trials

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Other Devices by Nu Vasive, Incorporated

K162138NuVasive CoRoent Small Ti-C System K161014NuVasive® Reline® System K161442NuVasive® CoRoent® Small Interlock™ System K161230NuVasive Lumbar Interbody Implants K161265NuVasive® VersaTie System K153105MLX™ - Medial Lateral Expandable Lumbar Interbody System

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Related Devices (Code: MQP)

K172330Blustone Synergy Silica SystemBlustone Synergy K173125T2 STRATOSPHERE™ Expandable Corpectomy SystemMedtronic Sofamor Danek K162315FORTIFY Corpectomy SpacersGlobus Medical, Inc. K172323Omnia Medical VBROmnia Medical, LLC K171686Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) SystemChoicespine K171704CAPRI Corpectomy Cage SystemK2m

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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