Carlsmed, Inc.
FDA 510(k) & PMA Approved Devices — 21 products
Total Devices21
Categories6
Latest FDA decision2026-05-09
SEC Filings: 1 filings on record. Latest: 10-Q (2026-08-05). View on SEC EDGAR →
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K260385 | aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and transforaminal lumbar interbody system; aprevo® cervical interbody system; corra™ cervical plating system | MAX | 2026-05-09 | View |
| 510(k) | K260570 | corra™ cervical plating system | KWQ | 2026-04-22 | View |
| 510(k) | K252894 | aprevo® cervical interbody system | ODP | 2026-01-06 | View |
| 510(k) | K252611 | aprevo® cervical plating system | KWQ | 2025-12-22 | View |
| 510(k) | 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 | View |
| 510(k) | K250987 | aprevo® posterior/transforaminal lumbar interbody fusion device | MAX | 2025-06-30 | View |
| 510(k) | K243802 | aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar interbody fusion device with interfixation | OVD | 2025-03-17 | View |
| 510(k) | K242599 | aprevo® Digital Planning | LLZ | 2024-12-20 | View |
| 510(k) | K243635 | aprevo® anterior lumbar interbody fusion device with interfixation | OVD | 2024-12-13 | View |
| 510(k) | K242260 | aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAM | ODP | 2024-11-15 | View |
| 510(k) | K241477 | aprevo® anterior lumbar interbody fusion device with interfixation | OVD | 2024-10-09 | View |
| 510(k) | 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 | View |
| 510(k) | 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 | View |
| 510(k) | K232282 | aprevo® anterior and lateral lumbar interbody fusion device, aprevo® transforaminal lumbar interbody fusion device | MAX | 2024-03-22 | View |
| 510(k) | K231955 | aprevo® Digital Segmentation | QIH | 2023-11-03 | View |
| 510(k) | K231140 | aprevo® transforaminal lumbar interbody fusion device | MAX | 2023-05-19 | View |
| 510(k) | K222195 | aprevo® Digital Workflow | LLZ | 2022-12-30 | View |
| 510(k) | K222009 | aprevo® anterior lumbar interbody fusion device with interfixation | OVD | 2022-11-22 | View |
| 510(k) | K222082 | aprevo® anterior and lateral lumbar interbody fusion devices, aprevo® transforaminal lumbar interbody fusion devices | MAX | 2022-08-12 | View |
| 510(k) | K210542 | aprevo Transforaminal IBF | MAX | 2021-06-30 | View |
No matching devices.
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