Carlsmed

FDA Regulatory Profile

Carlsmed appears in FDA public data with 0 recalls, 22 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on May 9, 2026.

Summary

Total Recalls
0
510(k) Clearances
22
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and transforaminal lumbar inMay 9, 2026
K260570corra™ cervical plating systemApr 22, 2026
K252894aprevo® cervical interbody systemJan 6, 2026
K252611aprevo® cervical plating systemDec 22, 2025
K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion device; aprJul 7, 2025
K250987aprevo® posterior/transforaminal lumbar interbody fusion deviceJun 30, 2025
K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar interbody fusioMar 17, 2025
K242599aprevo® Digital PlanningDec 20, 2024
K243635aprevo® anterior lumbar interbody fusion device with interfixationDec 13, 2024
K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMNov 15, 2024
K241477aprevo® anterior lumbar interbody fusion device with interfixationOct 9, 2024
K241332aprevo® anterior and lateral lumbar interbody fusion device; aprevo® anterior lumbar interbody fusioSep 20, 2024
K241328aprevo® Anterior and Lateral Lumbar Interbody Fusion device (ALIF/LLIF); aprevo® Transforaminal LumbAug 12, 2024
K241019aprevo® TLIF-C Articulating SystemJul 9, 2024
K232282aprevo® anterior and lateral lumbar interbody fusion device, aprevo® transforaminal lumbar interbodyMar 22, 2024
K231955aprevo® Digital SegmentationNov 3, 2023
K231140aprevo® transforaminal lumbar interbody fusion deviceMay 19, 2023
K222195aprevo® Digital WorkflowDec 30, 2022
K222009aprevo® anterior lumbar interbody fusion device with interfixationNov 22, 2022
K222082aprevo® anterior and lateral lumbar interbody fusion devices, aprevo® transforaminal lumbar interbodAug 12, 2022