Aprevo® Anterior And Lateral Lumbar Interbody Fusion Devices, Aprevo® Transforaminal Lumbar Interbody Fusion Devices
Carlsmed, Inc.
CARLSMED, INC.
FDA Registration(s)
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3017936978 | 3017936978 | CARLSMED, INC. | 1 | N | 2026-01-01 | 1800 Aston Avenue Suite 100 Carlsbad CA US 92008 |
Registered Device Listings
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 286973 | 1727839231 | K252894 | aprevo® cervical interbody system | ODP | 2026-01-06 |
| 286973 | 1746495386 | K252611 | aprevo® cervical plating system | KWQ | 2025-12-22 |
| 286973 | 1516647810 | K250987 | aprevo® posterior/transforaminal lumbar interbody fusion device | MAX | 2025-06-30 |
| 286973 | 1301764113 | K250827 | 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; aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X No Cams | MAX | 2025-07-07 |
| 286973 | 1396967276 | K243802 | aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar interbody fusion device with interfixation | OVD | 2025-03-17 |
| 286973 | 2004311750 | K243635 | aprevo® anterior lumbar interbody fusion device with interfixation | OVD | 2024-12-13 |
| 286973 | 1872595446 | K242599 | aprevo® Digital Planning | LLZ | 2024-12-20 |
| 286973 | 1111701582 | K242260 | aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAM | ODP | 2024-11-15 |
| 286973 | 2014853598 | K241477 | aprevo® anterior lumbar interbody fusion device with interfixation | OVD | 2024-10-09 |
| 286973 | 1865009295 | K241332 | aprevo® anterior and lateral lumbar interbody fusion device; aprevo® anterior lumbar interbody fusion devices with interfixation; aprevo® transforaminal lumbar interbody fusion device | MAX | 2024-09-20 |
| 286973 | 1057312975 | K241328 | aprevo® Anterior and Lateral Lumbar Interbody Fusion device (ALIF/LLIF); aprevo® Transforaminal Lumbar Interbody Fusion device (TLIF); aprevo® Anterior Lumbar Interbody Fusion device with Interfixation (ALIF-X) | MAX | 2024-08-12 |
| 286973 | 1619956826 | K241019 | aprevo® TLIF-C Articulating System | MAX | 2024-07-09 |
| 286973 | 1798301490 | K232282 | aprevo® anterior and lateral lumbar interbody fusion device, aprevo® transforaminal lumbar interbody fusion device | MAX | 2024-03-22 |
| 286973 | 1379664988 | K231955 | aprevo® Digital Segmentation | QIH | 2023-11-03 |
| 286973 | 1951173753 | K231140 | aprevo® transforaminal lumbar interbody fusion device | MAX | 2023-05-19 |
| 286973 | 1135695898 | K222195 | aprevo® Digital Workflow | LLZ | 2022-12-30 |
| 286973 | 1494238031 | K222082 | aprevo® anterior and lateral lumbar interbody fusion devices, aprevo® transforaminal lumbar interbody fusion devices | MAX | 2022-08-12 |
| 286973 | 2047331398 | K222009 | aprevo® anterior lumbar interbody fusion device with interfixation | OVD | 2022-11-22 |
| 286973 | 1085768627 | K210542 | aprevo Transforaminal IBF | MAX | 2021-06-30 |
| 286973 | 1034428198 | K202034 | aprevo Intervertebral Body Fusion Device | MAX | 2020-12-03 |
| 286973 | 1010734301 | ||||
| 286973 | 1193059536 | ||||
| 286973 | 1799329698 | ||||
| 286973 | 1872501274 |
Product Codes Associated With Registrations
PMA
PMN
Applications
GUDID
aprevo
Carlsmed, Inc.
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