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FDA 510(k)

EVOS Lumbar Interbody System

K-Number: K200552 · 2020-04-02

ApplicantCutting Edge Spine, LLC
Decision Date2020-04-02
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EVOS Lumbar Interbody System is a medical device manufactured by Cutting Edge Spine, LLC. It received FDA 510(k) clearance on 2020-04-02 under approval number K200552. 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 EVOS Lumbar Interbody System?

EVOS Lumbar Interbody System is a medical device that received FDA 510(k) clearance on 2020-04-02. It is manufactured by Cutting Edge Spine, LLC. The 510(k) number is K200552.

When was EVOS Lumbar Interbody System approved by the FDA?

EVOS Lumbar Interbody System received FDA 510(k) clearance on 2020-04-02, under approval number K200552.

What company makes EVOS Lumbar Interbody System?

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

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

The FDA product code for EVOS 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 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 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 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.

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