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FDA 510(k)

Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF)

K-Number: K232996 · 2024-09-06

ApplicantShanghai Iatrical-Ti Technologies CO , Ltd.
Decision Date2024-09-06
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF) is a medical device manufactured by Shanghai Iatrical-Ti Technologies CO , Ltd.. It received FDA 510(k) clearance on 2024-09-06 under approval number K232996. 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 Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF)?

Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF) is a medical device that received FDA 510(k) clearance on 2024-09-06. It is manufactured by Shanghai Iatrical-Ti Technologies CO , Ltd.. The 510(k) number is K232996.

When was Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF) approved by the FDA?

Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF) received FDA 510(k) clearance on 2024-09-06, under approval number K232996.

What company makes Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF)?

Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF) is manufactured by Shanghai Iatrical-Ti Technologies CO , Ltd..

What is the FDA product code for Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF)?

The FDA product code for Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF) 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 NCT03053791 Deep Brain Stimulation in Patients With Incomplete Spinal Cord Injury for Improvement of Gait RECRUITING NCT07608302 Comparison of the Predictability of Dentoalveolar Expansion With Two Clear Aligner Systems COMPLETED NCT06462729 LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF) RECRUITING NCT05438719 MOTUS Total Joint Replacement Investigational Device Exemption 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) PMID: 40006413 Data Reconstruction Methods in Multi-Feature Fusion CNN Model for Enhanced Human Activity Recognition. Sensors (Basel, Switzerland) (2025)

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.

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