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FDA 510(k)

NuVasive Cohere Thoracolumbar Interbody System

K-Number: K193541 · 2020-03-30

ApplicantNu Vasive, Incorporated
Decision Date2020-03-30
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 2020-03-30 under approval number K193541. 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 2020-03-30. It is manufactured by Nu Vasive, Incorporated. The 510(k) number is K193541.

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

NuVasive Cohere Thoracolumbar Interbody System received FDA 510(k) clearance on 2020-03-30, under approval number K193541.

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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