Carlsmed, Inc. - FDA 510(k) Cleared Devices

Carlsmed, Inc. is a medical technology company pioneering personalized spine surgery solutions. The company develops the aprevo® platform, an end-to-end system for patient-specific spinal implants and surgical planning. Carlsmed operates with a manufacturing facility in La Jolla, California.

The company has received 21 FDA 510(k) clearances from 21 total submissions since its first clearance in 2020. Orthopedic devices represent the dominant focus, comprising approximately 85% of submissions. Recent clearances span Orthopedic spinal fusion systems for cervical and lumbar indications, with the latest clearance in 2026, demonstrating continued regulatory activity.

The aprevo® portfolio includes personalized interbody fusion devices and plating systems designed for anterior cervical discectomy and fusion (ACDF), anterior lumbar interbody fusion (ALIF), lateral lumbar interbody fusion (LLIF), and transforaminal approaches. Each device is tailored to individual patient anatomy using 3D surgical planning and visualization technology.

Explore the complete regulatory history, device names, product codes, and clearance dates in the 510(k) database.

Regulatory submissions have been managed by Empirical Testing Corp and Karen Liu Consulting.