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Carlsmed, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
20
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K252894aprevo® cervical interbody systemJanuary 6, 2026
K252611aprevo® cervical plating systemDecember 22, 2025
K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion device; aprJuly 7, 2025
K250987aprevo® posterior/transforaminal lumbar interbody fusion deviceJune 30, 2025
K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar interbody fusioMarch 17, 2025
K242599aprevo® Digital PlanningDecember 20, 2024
K243635aprevo® anterior lumbar interbody fusion device with interfixationDecember 13, 2024
K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMNovember 15, 2024
K241477aprevo® anterior lumbar interbody fusion device with interfixationOctober 9, 2024
K241332aprevo® anterior and lateral lumbar interbody fusion device; aprevo® anterior lumbar interbody fusioSeptember 20, 2024
K241328aprevo® Anterior and Lateral Lumbar Interbody Fusion device (ALIF/LLIF); aprevo® Transforaminal LumbAugust 12, 2024
K241019aprevo® TLIF-C Articulating SystemJuly 9, 2024
K232282aprevo® anterior and lateral lumbar interbody fusion device, aprevo® transforaminal lumbar interbodyMarch 22, 2024
K231955aprevo® Digital SegmentationNovember 3, 2023
K231140aprevo® transforaminal lumbar interbody fusion deviceMay 19, 2023
K222195aprevo® Digital WorkflowDecember 30, 2022
K222009aprevo® anterior lumbar interbody fusion device with interfixationNovember 22, 2022
K222082aprevo® anterior and lateral lumbar interbody fusion devices, aprevo® transforaminal lumbar interbodAugust 12, 2022
K210542aprevo Transforaminal IBFJune 30, 2021
K202034aprevo Intervertebral Body Fusion DeviceDecember 3, 2020