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FDA 510(k)

aprevo® cervical interbody system

K-Number: K252894 · 2026-01-06

ApplicantCarlsmed, Inc.
Decision Date2026-01-06
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

aprevo® cervical interbody system is a medical device manufactured by Carlsmed, Inc.. It received FDA 510(k) clearance on 2026-01-06 under approval number K252894. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the aprevo® cervical interbody system?

aprevo® cervical interbody system is a medical device that received FDA 510(k) clearance on 2026-01-06. It is manufactured by Carlsmed, Inc.. The 510(k) number is K252894.

When was aprevo® cervical interbody system approved by the FDA?

aprevo® cervical interbody system received FDA 510(k) clearance on 2026-01-06, under approval number K252894.

What company makes aprevo® cervical interbody system?

aprevo® cervical interbody system is manufactured by Carlsmed, Inc..

What is the FDA product code for aprevo® cervical interbody system?

The FDA product code for aprevo® cervical interbody system is ODP.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT07606196 The Effect of Otolith Dysfunction and Its Rehabilitation in Vestibular Diseases COMPLETED NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION NCT05489822 PMCF Study to Evaluate the VERTICALE® Cervical System in Spine Surgery According to Its Intended Use. TERMINATED NCT07153536 Spinal Cord Stimulation Combined With Physical Therapy in Post-Stroke Upper-Limb Motor Hemiparesis RECRUITING NCT05305430 Real World Data Collection on the Synergy Cervical Disc RECRUITING

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: ODP)

K161127The Small PLATEAU (PLATEAU-C) Spacer SystemLife Spine, Inc. K162003IMSE Cervical CageThe Institute of Musculoskeletal Science & Education K160222OIC Cervical PEEK SpacerThe Orthopaedic Implant Company K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc. K162220DIO Medical IVA (ACIF, DLIF, PLIF, TLIF,and ALIF) CageDio Medical Co., Ltd. K161649Virtu C Spinal Implant SystemMet 1 Technologies, LLC

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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