FDA 510(k)

aprevo® posterior/transforaminal lumbar interbody fusion device

K-Number: K250987 · 2025-06-30

Decision Date2025-06-30

Product CodeMAX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

aprevo® posterior/transforaminal lumbar interbody fusion device is a medical device manufactured by Carlsmed, Inc.. It received FDA 510(k) clearance on 2025-06-30 under approval number K250987. 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 aprevo® posterior/transforaminal lumbar interbody fusion device?

aprevo® posterior/transforaminal lumbar interbody fusion device is a medical device that received FDA 510(k) clearance on 2025-06-30. It is manufactured by Carlsmed, Inc.. The 510(k) number is K250987.

When was aprevo® posterior/transforaminal lumbar interbody fusion device approved by the FDA?

aprevo® posterior/transforaminal lumbar interbody fusion device received FDA 510(k) clearance on 2025-06-30, under approval number K250987.

What company makes aprevo® posterior/transforaminal lumbar interbody fusion device?

aprevo® posterior/transforaminal lumbar interbody fusion device is manufactured by Carlsmed, Inc..

What is the FDA product code for aprevo® posterior/transforaminal lumbar interbody fusion device?

The FDA product code for aprevo® posterior/transforaminal lumbar interbody 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 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 NCT07226193 Detecting Peripheral Artery Disease With the Pulse RECRUITING NCT07103941 IOA Preventing Occlusal Changes With MAD Use 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 Carlsmed, Inc.

K202034aprevo Intervertebral Body Fusion Device K210542aprevo Transforaminal IBF K222195aprevo® Digital Workflow K222009aprevo® anterior lumbar interbody fusion device with interfixation K222082aprevo® anterior and lateral lumbar interbody fusion devices, aprevo® transforaminal lumbar interbody fusion devices K231955aprevo® Digital Segmentation

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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.