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FDA 510(k)

DZ-Tabone Intervertebral Body Fusion Device

K-Number: K241073 · 2024-12-06

ApplicantShenzhen Dazhou Medical Technology Co., Ltd.
Decision Date2024-12-06
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DZ-Tabone Intervertebral Body Fusion Device is a medical device manufactured by Shenzhen Dazhou Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-12-06 under approval number K241073. 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 DZ-Tabone Intervertebral Body Fusion Device?

DZ-Tabone Intervertebral Body Fusion Device is a medical device that received FDA 510(k) clearance on 2024-12-06. It is manufactured by Shenzhen Dazhou Medical Technology Co., Ltd.. The 510(k) number is K241073.

When was DZ-Tabone Intervertebral Body Fusion Device approved by the FDA?

DZ-Tabone Intervertebral Body Fusion Device received FDA 510(k) clearance on 2024-12-06, under approval number K241073.

What company makes DZ-Tabone Intervertebral Body Fusion Device?

DZ-Tabone Intervertebral Body Fusion Device is manufactured by Shenzhen Dazhou Medical Technology Co., Ltd..

What is the FDA product code for DZ-Tabone Intervertebral Body Fusion Device?

The FDA product code for DZ-Tabone Intervertebral Body Fusion Device 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 NCT02759744 Fusion Guided Focal Laser Ablation of Prostate Cancer ENROLLING_BY_INVITATION NCT07516145 Robotic Transjugular Transcatheter Tricuspid Valve Replacement RECRUITING NCT04214535 Anterior Cervical Disectomy And Fusion Using The Tritanium® C Anterior Cervical Cage For One Or Two-Levels 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 Shenzhen Dazhou Medical Technology Co., Ltd.

K241186Synthetic Bone Graft Particulate

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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