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FDA 510(k)

NuVasive® CoRoent® Thoracolumbar System

K-Number: K170962 · 2017-06-26

ApplicantNu Vasive, Incorporated
Decision Date2017-06-26
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

NuVasive® CoRoent® Thoracolumbar System is a medical device manufactured by Nu Vasive, Incorporated. It received FDA 510(k) clearance on 2017-06-26 under approval number K170962. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NuVasive® CoRoent® Thoracolumbar System?

NuVasive® CoRoent® Thoracolumbar System is a medical device that received FDA 510(k) clearance on 2017-06-26. It is manufactured by Nu Vasive, Incorporated. The 510(k) number is K170962.

When was NuVasive® CoRoent® Thoracolumbar System approved by the FDA?

NuVasive® CoRoent® Thoracolumbar System received FDA 510(k) clearance on 2017-06-26, under approval number K170962.

What company makes NuVasive® CoRoent® Thoracolumbar System?

NuVasive® CoRoent® Thoracolumbar System is manufactured by Nu Vasive, Incorporated.

What is the FDA product code for NuVasive® CoRoent® Thoracolumbar System?

The FDA product code for NuVasive® CoRoent® Thoracolumbar System is MAX.

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: MAX)

K163180Hubble IIOrbbo Surgical, LLC K162446FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK Lateral Interbody Fusion SystemOrthofix, Inc. K162327COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL K162103Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine Interbody Fusion System (Harrier™), Choice Spine Vertebral Body Replacement System (Hawkeye™)Choicespine, LP K162431Luna 3D Interbody Fusion SystemBenvenue Medical, Inc. K160959Xsert Lumbar Expandable Interbody SystemX-Spine Systems, 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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