FDA 510(k) Applications Submitted by Carlsmed, Inc.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K242599 |
08/30/2024 |
aprevo« Digital Planning |
Carlsmed, Inc. |
| K250827 |
03/18/2025 |
aprevo« anterior lumbar interbody fusion device; aprevo« lateral lumbar interbody fusion device; aprevo« anterior lumbar interbody fusion device with interfixation; aprevo« transforaminal lumbar interbody fusion device; aprevo« TLIF-CA Articulating System |
Carlsmed, Inc. |
| K210542 |
02/24/2021 |
aprevo Transforaminal IBF |
Carlsmed, Inc. |
| K231140 |
04/21/2023 |
aprevo« transforaminal lumbar interbody fusion device |
Carlsmed, Inc. |
| K241332 |
05/10/2024 |
aprevo« anterior and lateral lumbar interbody fusion device; aprevo« anterior lumbar interbody fusion devices with interfixation; aprevo« transforaminal lumbar interbody fusion device |
Carlsmed, Inc. |
| K241477 |
05/24/2024 |
aprevo« anterior lumbar interbody fusion device with interfixation |
Carlsmed, Inc. |
| K231955 |
07/03/2023 |
aprevo« Digital Segmentation |
Carlsmed, Inc. |
| K222009 |
07/07/2022 |
aprevo« anterior lumbar interbody fusion device with interfixation |
Carlsmed, Inc. |
| K222082 |
07/15/2022 |
aprevo« anterior and lateral lumbar interbody fusion devices, aprevo« transforaminal lumbar interbody fusion devices |
Carlsmed, Inc. |
| K222195 |
07/22/2022 |
aprevo« Digital Workflow |
Carlsmed, Inc. |
| K232282 |
07/31/2023 |
aprevo« anterior and lateral lumbar interbody fusion device, aprevo« transforaminal lumbar interbody fusion device |
Carlsmed, Inc. |
| K243802 |
12/11/2024 |
aprevo« anterior and lateral lumbar interbody fusion device, aprevo« anterior lumbar interbody fusion device with interfixation |
Carlsmed, Inc. |
| K243635 |
11/25/2024 |
aprevo« anterior lumbar interbody fusion device with interfixation |
Carlsmed, Inc. |
| K202034 |
07/23/2020 |
aprevo Intervertebral Body Fusion Device |
Carlsmed, Inc. |
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