FDA 510(k)

MLX - Medial Lateral Expandable Lumbar Interbody System

K-Number: K153105 · 2016-07-11

Decision Date2016-07-11

Product CodeMAX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

MLX - Medial Lateral Expandable Lumbar Interbody System is a medical device manufactured by Nu Vasive, Incorporated. It received FDA 510(k) clearance on 2016-07-11 under approval number K153105. 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 MLX - Medial Lateral Expandable Lumbar Interbody System?

MLX - Medial Lateral Expandable Lumbar Interbody System is a medical device that received FDA 510(k) clearance on 2016-07-11. It is manufactured by Nu Vasive, Incorporated. The 510(k) number is K153105.

When was MLX - Medial Lateral Expandable Lumbar Interbody System approved by the FDA?

MLX - Medial Lateral Expandable Lumbar Interbody System received FDA 510(k) clearance on 2016-07-11, under approval number K153105.

What company makes MLX - Medial Lateral Expandable Lumbar Interbody System?

MLX - Medial Lateral Expandable Lumbar Interbody System is manufactured by Nu Vasive, Incorporated.

What is the FDA product code for MLX - Medial Lateral Expandable Lumbar Interbody System?

The FDA product code for MLX - Medial Lateral Expandable Lumbar 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 NCT07616050 Evaluation of the Impact of Virtual Park on Training Motivation in Adult Patients NOT_YET_RECRUITING NCT05391828 Persona MC vs PS RCT With ROSA RECRUITING NCT05508360 "Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2) RECRUITING NCT06462729 LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF) RECRUITING NCT05438719 MOTUS Total Joint Replacement Investigational Device Exemption Study 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 K161230NuVasive Lumbar Interbody Implants K161265NuVasive® VersaTie 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.