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FDA 510(k)

Expandable Lumbar Fusion Cage (Type I,Type II)

K-Number: K232069 · 2023-11-29

ApplicantShanghai Reach Medical Instrument Co, Ltd.
Decision Date2023-11-29
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Expandable Lumbar Fusion Cage (Type I,Type II) is a medical device manufactured by Shanghai Reach Medical Instrument Co, Ltd.. It received FDA 510(k) clearance on 2023-11-29 under approval number K232069. 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 Expandable Lumbar Fusion Cage (Type I,Type II)?

Expandable Lumbar Fusion Cage (Type I,Type II) is a medical device that received FDA 510(k) clearance on 2023-11-29. It is manufactured by Shanghai Reach Medical Instrument Co, Ltd.. The 510(k) number is K232069.

When was Expandable Lumbar Fusion Cage (Type I,Type II) approved by the FDA?

Expandable Lumbar Fusion Cage (Type I,Type II) received FDA 510(k) clearance on 2023-11-29, under approval number K232069.

What company makes Expandable Lumbar Fusion Cage (Type I,Type II)?

Expandable Lumbar Fusion Cage (Type I,Type II) is manufactured by Shanghai Reach Medical Instrument Co, Ltd..

What is the FDA product code for Expandable Lumbar Fusion Cage (Type I,Type II)?

The FDA product code for Expandable Lumbar Fusion Cage (Type I,Type II) 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 NCT07017634 Efficacy and Safety of Novosis Putty in Transforaminal Lumbar Interbody Fusion for Patients With Lumbar Degenerative Disc Disease RECRUITING NCT07059065 FIBERGRAFT Aeridyan Posterolateral Fusion Study 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 Shanghai Reach Medical Instrument Co, Ltd.

K201737Posterior Spinal Fixation System K221745Sterile Posterior Spinal Fixation 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

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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