Carlsmed, Inc. - FDA 510(k) Cleared Devices
Recent clearances: corra® cervical plating system, aprevo® anterior and lateral lumbar interbody system, corra™ cervical plating system
22
Total
22
Cleared
0
Denied
FDA 510(k) Regulatory Record - Carlsmed, Inc. Orthopedic ✕
19 devices
Cleared
Sep 24, 2026
corra® cervical plating system
Orthopedic
91d
Cleared
May 09, 2026
aprevo® anterior and lateral lumbar interbody system
Orthopedic
92d
Cleared
Apr 22, 2026
corra™ cervical plating system
Orthopedic
62d
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 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