FDA 510(k)

Eminent Spine 3D Lumbar Interbody Fusion Systems

K-Number: K230219 · 2023-05-16

Decision Date2023-05-16

Product CodeMAX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Eminent Spine 3D Lumbar Interbody Fusion Systems is a medical device manufactured by Eminent Spine, LLC. It received FDA 510(k) clearance on 2023-05-16 under approval number K230219. 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 Eminent Spine 3D Lumbar Interbody Fusion Systems?

Eminent Spine 3D Lumbar Interbody Fusion Systems is a medical device that received FDA 510(k) clearance on 2023-05-16. It is manufactured by Eminent Spine, LLC. The 510(k) number is K230219.

When was Eminent Spine 3D Lumbar Interbody Fusion Systems approved by the FDA?

Eminent Spine 3D Lumbar Interbody Fusion Systems received FDA 510(k) clearance on 2023-05-16, under approval number K230219.

What company makes Eminent Spine 3D Lumbar Interbody Fusion Systems?

Eminent Spine 3D Lumbar Interbody Fusion Systems is manufactured by Eminent Spine, LLC.

What is the FDA product code for Eminent Spine 3D Lumbar Interbody Fusion Systems?

The FDA product code for Eminent Spine 3D Lumbar Interbody Fusion Systems is MAX.

Related Clinical Trials

NCT07615491 PMCF Study on the Effectiveness and Safety of METROSAN Spinal Systems and BONEGRAFT Filling Materials RECRUITING NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes 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: 41839575 A Perspective for Integrating Real-World Evidence Into the Investigational Device Exemption Study Design for Lumbar Total Joint Replacement. International journal of spine surgery (2026) PMID: 38273730 Ten-Year Risk of Recall of Novel Spine Devices. Spine (2024) PMID: 37504879 Comparative Evaluation of Mineralized Bone Allografts for Spinal Fusion Surgery. Journal of functional biomaterials (2023) PMID: 36074993 Reported Events Associated With Spine Robots: An Analysis of the Food and Drug Administration's Manufacturer and User Facility Device Experience Database. Global spine journal (2023)

Other Devices by Eminent Spine, LLC

K201979Cervical Plate System K212853Cervical Stand-Alone System K240505Eminent Spine SI Screw System

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.