FDA 510(k)

NuVasive Lumbar Interbody Implants

K-Number: K161230 · 2016-08-25

Decision Date2016-08-25

Product CodeMAX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

NuVasive Lumbar Interbody Implants is a medical device manufactured by Nu Vasive, Incorporated. It received FDA 510(k) clearance on 2016-08-25 under approval number K161230. 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 Lumbar Interbody Implants?

NuVasive Lumbar Interbody Implants is a medical device that received FDA 510(k) clearance on 2016-08-25. It is manufactured by Nu Vasive, Incorporated. The 510(k) number is K161230.

When was NuVasive Lumbar Interbody Implants approved by the FDA?

NuVasive Lumbar Interbody Implants received FDA 510(k) clearance on 2016-08-25, under approval number K161230.

What company makes NuVasive Lumbar Interbody Implants?

NuVasive Lumbar Interbody Implants is manufactured by Nu Vasive, Incorporated.

What is the FDA product code for NuVasive Lumbar Interbody Implants?

The FDA product code for NuVasive Lumbar Interbody Implants is MAX.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT06462729 LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF) RECRUITING NCT05438719 MOTUS Total Joint Replacement Investigational Device Exemption Study ACTIVE_NOT_RECRUITING NCT04823858 3Spine Lumbar Fusion Real World Evidence Study ACTIVE_NOT_RECRUITING NCT07017634 Efficacy and Safety of Novosis Putty in Transforaminal Lumbar Interbody Fusion for Patients With Lumbar Degenerative Disc Disease RECRUITING NCT06904898 CONDUIT vs. PEEK Cages ACTIVE_NOT_RECRUITING

Related PubMed Literature

PMID: 41166829 Assessment of intra-operative impact durability of additively manufactured mock lumbar intervertebral body fusion devices. Journal of biomechanics (2026)

Other Devices by Nu Vasive, Incorporated

K162138NuVasive CoRoent Small Ti-C System K161014NuVasive® Reline® System K161442NuVasive® CoRoent® Small Interlock System K161265NuVasive® VersaTie System K153105MLX - Medial Lateral Expandable Lumbar Interbody System K160916CoRoent® Ti-C 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.