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FDA 510(k)

CancelleX Porous Titanium Lumbar Interbody Device

K-Number: K190364 · 2019-04-18

ApplicantXenco Medical, LLC
Decision Date2019-04-18
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CancelleX Porous Titanium Lumbar Interbody Device is a medical device manufactured by Xenco Medical, LLC. It received FDA 510(k) clearance on 2019-04-18 under approval number K190364. 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 CancelleX Porous Titanium Lumbar Interbody Device?

CancelleX Porous Titanium Lumbar Interbody Device is a medical device that received FDA 510(k) clearance on 2019-04-18. It is manufactured by Xenco Medical, LLC. The 510(k) number is K190364.

When was CancelleX Porous Titanium Lumbar Interbody Device approved by the FDA?

CancelleX Porous Titanium Lumbar Interbody Device received FDA 510(k) clearance on 2019-04-18, under approval number K190364.

What company makes CancelleX Porous Titanium Lumbar Interbody Device?

CancelleX Porous Titanium Lumbar Interbody Device is manufactured by Xenco Medical, LLC.

What is the FDA product code for CancelleX Porous Titanium Lumbar Interbody Device?

The FDA product code for CancelleX Porous Titanium Lumbar Interbody Device is MAX.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT07610850 Brain-controlled Spinal Cord Stimulation in Participants With Chronic Stroke for Lower and Upper Limb Rehabilitation 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 NCT06430268 Efficacy of Non-surgical and Surgical Surface Decontamination Methods on Peri-implantitis-affected Implants ENROLLING_BY_INVITATION NCT04823858 3Spine Lumbar Fusion Real World Evidence Study ACTIVE_NOT_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 Xenco Medical, LLC

K160313Xenco Medical Cervical Interbody System K161478Xenco Medical Posterior Cervical System K160986Xenco Medical Pedicle Screw System K170611SETx Pedicle Screw System K173933Sorrento Bioglass Bone Graft Substitute K180373CancelleX Porous Titanium Lumbar Interbody Device

View all 11 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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