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FDA 510(k)

NuVasive® Cohere® Thoracolumbar Interbody System

K-Number: K200953 · 2020-10-06

ApplicantNu Vasive, Incorporated
Decision Date2020-10-06
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

NuVasive® Cohere® Thoracolumbar Interbody System is a medical device manufactured by Nu Vasive, Incorporated. It received FDA 510(k) clearance on 2020-10-06 under approval number K200953. 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® Cohere® Thoracolumbar Interbody System?

NuVasive® Cohere® Thoracolumbar Interbody System is a medical device that received FDA 510(k) clearance on 2020-10-06. It is manufactured by Nu Vasive, Incorporated. The 510(k) number is K200953.

When was NuVasive® Cohere® Thoracolumbar Interbody System approved by the FDA?

NuVasive® Cohere® Thoracolumbar Interbody System received FDA 510(k) clearance on 2020-10-06, under approval number K200953.

What company makes NuVasive® Cohere® Thoracolumbar Interbody System?

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

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

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

Related Clinical Trials

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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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