Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

aprevo® cervical plating system

K-Number: K252611 · 2025-12-22

ApplicantCarlsmed, Inc.
Decision Date2025-12-22
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

aprevo® cervical plating system is a medical device manufactured by Carlsmed, Inc.. It received FDA 510(k) clearance on 2025-12-22 under approval number K252611. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the aprevo® cervical plating system?

aprevo® cervical plating system is a medical device that received FDA 510(k) clearance on 2025-12-22. It is manufactured by Carlsmed, Inc.. The 510(k) number is K252611.

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

aprevo® cervical plating system received FDA 510(k) clearance on 2025-12-22, under approval number K252611.

What company makes aprevo® cervical plating system?

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

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

The FDA product code for aprevo® cervical plating system is KWQ.

Related Clinical Trials

NCT07606196 The Effect of Otolith Dysfunction and Its Rehabilitation in Vestibular Diseases COMPLETED 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Disc RECRUITING NCT05880823 Post Market Data Collection Protocol to Evaluate the Performance of the Synergy Disc WITHDRAWN NCT06383962 Post-Market Data Collection to Evaluate the Performance of the Synergy Disc® RECRUITING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

View all 21 devices →

Related Devices (Code: KWQ)

K160982Sphynx™Eden Spine, LLC K162638CETRA Anterior Cervical Plate SystemOrthofix, Inc. K162194MEDICREA INTERNATIONAL Anterior Cervical Locking Plate SystemMedicrea International SA K162211AccuFit Lateral Plate SystemPrecision Spine, Inc. K162250FortiBridge Anterior Cervical Plate SystemNanovis Spine, LLC K162664Pyrenees Cervical Plate SystemK2m, 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.

↑