FDA 510(k)

EVOL Spinal Interbody System

K-Number: K200991 · 2020-05-13

Decision Date2020-05-13

Product CodeMAX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

EVOL Spinal Interbody System is a medical device manufactured by Cutting Edge Spine, LLC. It received FDA 510(k) clearance on 2020-05-13 under approval number K200991. 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?

EVOL Spinal Interbody System is a medical device that received FDA 510(k) clearance on 2020-05-13. It is manufactured by Cutting Edge Spine, LLC. The 510(k) number is K200991.

When was EVOL Spinal Interbody System approved by the FDA?

EVOL Spinal Interbody System received FDA 510(k) clearance on 2020-05-13, under approval number K200991.

What company makes EVOL Spinal Interbody System?

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

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

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

Related Clinical Trials

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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 K180891EVOL Spinal Interbody System, EVOS Lumbar Interbody System K190025EVOL® -SI Joint Fusion System K200552EVOS Lumbar Interbody System K192497EVOL ha - D Lateral Interbody Fusion System K214123T-FIX® 3DSI Joint Fusion 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.