Carlsmed, Inc. - FDA 510(k) Cleared Devices
19
Total
19
Cleared
0
Denied
Carlsmed, Inc. has 19 FDA 510(k) cleared orthopedic devices. Based in La Jolla, US.
Latest FDA clearance: Jan 2026. Active since 2020.
Browse the complete list of FDA 510(k) cleared orthopedic devices from this manufacturer. Filter by specialty or product code using the sidebar.
FDA 510(k) cleared devices by Carlsmed, Inc.
19 devices
Cleared
Jan 06, 2026
aprevo® cervical interbody system
Orthopedic
117d
Cleared
Dec 22, 2025
aprevo® cervical plating system
Orthopedic
126d
Cleared
Jul 07, 2025
aprevo® anterior lumbar interbody fusion device
Orthopedic
111d
Cleared
Jun 30, 2025
aprevo® posterior/transforaminal lumbar interbody fusion device
Orthopedic
91d
Cleared
Mar 17, 2025
aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior...
Orthopedic
96d
Cleared
Dec 20, 2024
aprevo® Digital Planning
Radiology
112d
Cleared
Dec 13, 2024
aprevo® anterior lumbar interbody fusion device with interfixation
Orthopedic
18d
Cleared
Nov 15, 2024
aprevo® Cervical ACDF
Orthopedic
107d
Cleared
Oct 09, 2024
aprevo® anterior lumbar interbody fusion device with interfixation
Orthopedic
138d
Cleared
Sep 20, 2024
aprevo® anterior and lateral lumbar interbody fusion device
Orthopedic
133d
Cleared
Aug 12, 2024
aprevo® Anterior and Lateral Lumbar Interbody Fusion device (ALIF/LLIF)
Orthopedic
94d
Cleared
Mar 22, 2024
aprevo® anterior and lateral lumbar interbody fusion device, aprevo®...
Orthopedic
235d