FDA 510(k)

CONDUIT Lateral Lumbar Intervertebral Fusion Cage, CONDUIT Instruments

K-Number: K223688 · 2023-03-08

Decision Date2023-03-08

Product CodeMAX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

CONDUIT Lateral Lumbar Intervertebral Fusion Cage, CONDUIT Instruments is a medical device manufactured by Medos International Sàrl. It received FDA 510(k) clearance on 2023-03-08 under approval number K223688. 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 CONDUIT Lateral Lumbar Intervertebral Fusion Cage, CONDUIT Instruments?

CONDUIT Lateral Lumbar Intervertebral Fusion Cage, CONDUIT Instruments is a medical device that received FDA 510(k) clearance on 2023-03-08. It is manufactured by Medos International Sàrl. The 510(k) number is K223688.

When was CONDUIT Lateral Lumbar Intervertebral Fusion Cage, CONDUIT Instruments approved by the FDA?

CONDUIT Lateral Lumbar Intervertebral Fusion Cage, CONDUIT Instruments received FDA 510(k) clearance on 2023-03-08, under approval number K223688.

What company makes CONDUIT Lateral Lumbar Intervertebral Fusion Cage, CONDUIT Instruments?

CONDUIT Lateral Lumbar Intervertebral Fusion Cage, CONDUIT Instruments is manufactured by Medos International Sàrl.

What is the FDA product code for CONDUIT Lateral Lumbar Intervertebral Fusion Cage, CONDUIT Instruments?

The FDA product code for CONDUIT Lateral Lumbar Intervertebral Fusion Cage, CONDUIT Instruments is MAX.

Related Clinical Trials

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 NCT06011551 HYDRAFIL-D: HYDRogel Augmentation For Intervertebral Lumbar Discs RECRUITING NCT07017634 Efficacy and Safety of Novosis Putty in Transforaminal Lumbar Interbody Fusion for Patients With Lumbar Degenerative Disc Disease RECRUITING

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: 41166829 Assessment of intra-operative impact durability of additively manufactured mock lumbar intervertebral body fusion devices. Journal of biomechanics (2026)

Other Devices by Medos International Sàrl

K160879CONFIDENCE High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated Screw Systems K200245EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine System K231527TriALTIS Navigation Enabled Instruments

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.