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FDA 510(k)

NuVasive CoRoent Thoracolumbar System

K-Number: K153419 · 2016-04-13

ApplicantNu Vasive, Incorporated
Decision Date2016-04-13
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 2016-04-13 under approval number K153419. 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 2016-04-13. It is manufactured by Nu Vasive, Incorporated. The 510(k) number is K153419.

When was NuVasive CoRoent Thoracolumbar System approved by the FDA?

NuVasive CoRoent Thoracolumbar System received FDA 510(k) clearance on 2016-04-13, under approval number K153419.

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

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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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