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FDA 510(k)

NuVasive Modulus XLIF Interbody System

K-Number: K192760 · 2019-10-18

ApplicantNu Vasive, Incorporated
Decision Date2019-10-18
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

NuVasive Modulus XLIF Interbody System is a medical device manufactured by Nu Vasive, Incorporated. It received FDA 510(k) clearance on 2019-10-18 under approval number K192760. 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 Modulus XLIF Interbody System?

NuVasive Modulus XLIF Interbody System is a medical device that received FDA 510(k) clearance on 2019-10-18. It is manufactured by Nu Vasive, Incorporated. The 510(k) number is K192760.

When was NuVasive Modulus XLIF Interbody System approved by the FDA?

NuVasive Modulus XLIF Interbody System received FDA 510(k) clearance on 2019-10-18, under approval number K192760.

What company makes NuVasive Modulus XLIF Interbody System?

NuVasive Modulus XLIF Interbody System is manufactured by Nu Vasive, Incorporated.

What is the FDA product code for NuVasive Modulus XLIF Interbody System?

The FDA product code for NuVasive Modulus XLIF Interbody System is MAX.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION

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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