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FDA 510(k)

EVOL ha - D Lateral Interbody Fusion System

K-Number: K192497 · 2020-01-06

ApplicantCutting Edge Spine, LLC
Decision Date2020-01-06
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EVOL ha - D Lateral Interbody Fusion System is a medical device manufactured by Cutting Edge Spine, LLC. It received FDA 510(k) clearance on 2020-01-06 under approval number K192497. 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 ha - D Lateral Interbody Fusion System?

EVOL ha - D Lateral Interbody Fusion System is a medical device that received FDA 510(k) clearance on 2020-01-06. It is manufactured by Cutting Edge Spine, LLC. The 510(k) number is K192497.

When was EVOL ha - D Lateral Interbody Fusion System approved by the FDA?

EVOL ha - D Lateral Interbody Fusion System received FDA 510(k) clearance on 2020-01-06, under approval number K192497.

What company makes EVOL ha - D Lateral Interbody Fusion System?

EVOL ha - D Lateral Interbody Fusion System is manufactured by Cutting Edge Spine, LLC.

What is the FDA product code for EVOL ha - D Lateral Interbody Fusion System?

The FDA product code for EVOL ha - D Lateral Interbody Fusion 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 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 NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION

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 Cutting Edge Spine, LLC

K180674EVOL® ha-C Cervical Interbody Fusion System K180891EVOL Spinal Interbody System, EVOS Lumbar Interbody System K190025EVOL® -SI Joint Fusion System K200991EVOL Spinal Interbody System K200552EVOS Lumbar Interbody 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.

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