FDA 510(k)

EVOL Spinal Interbody System, EVOS Lumbar Interbody System

K-Number: K180891 · 2018-05-04

Decision Date2018-05-04

Product CodeMAX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

EVOL Spinal Interbody System, EVOS Lumbar Interbody System is a medical device manufactured by Cutting Edge Spine, LLC. It received FDA 510(k) clearance on 2018-05-04 under approval number K180891. 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 EVOL Spinal Interbody System, EVOS Lumbar Interbody System?

EVOL Spinal Interbody System, EVOS Lumbar Interbody System is a medical device that received FDA 510(k) clearance on 2018-05-04. It is manufactured by Cutting Edge Spine, LLC. The 510(k) number is K180891.

When was EVOL Spinal Interbody System, EVOS Lumbar Interbody System approved by the FDA?

EVOL Spinal Interbody System, EVOS Lumbar Interbody System received FDA 510(k) clearance on 2018-05-04, under approval number K180891.

What company makes EVOL Spinal Interbody System, EVOS Lumbar Interbody System?

EVOL Spinal Interbody System, EVOS Lumbar Interbody System is manufactured by Cutting Edge Spine, LLC.

What is the FDA product code for EVOL Spinal Interbody System, EVOS Lumbar Interbody System?

The FDA product code for EVOL Spinal Interbody System, EVOS Lumbar Interbody System is MAX.

Related Clinical Trials

NCT06998134 Toward Ubiquitous Lower Limb Exoskeleton Use in Children and Young Adults RECRUITING NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT03053791 Deep Brain Stimulation in Patients With Incomplete Spinal Cord Injury for Improvement of Gait RECRUITING NCT07616050 Evaluation of the Impact of Virtual Park on Training Motivation in Adult Patients NOT_YET_RECRUITING NCT07610850 Brain-controlled Spinal Cord Stimulation in Participants With Chronic Stroke for Lower and Upper Limb Rehabilitation NOT_YET_RECRUITING NCT05508360 "Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2) RECRUITING

Related PubMed Literature

PMID: 41612341 Brain-computer interface commercialization. Journal of neuroengineering and rehabilitation (2026) PMID: 41166829 Assessment of intra-operative impact durability of additively manufactured mock lumbar intervertebral body fusion devices. Journal of biomechanics (2026) PMID: 39726899 How to improve the mechanical safety of a novel spinal implant while saving costs and time. JOR spine (2024)

Other Devices by Cutting Edge Spine, LLC

K180674EVOL® ha-C Cervical Interbody Fusion System K190025EVOL® -SI Joint Fusion System K200991EVOL Spinal Interbody System K200552EVOS Lumbar Interbody System K192497EVOL ha - D Lateral Interbody Fusion System K214123T-FIX® 3DSI Joint Fusion System

View all 9 devices →

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.