Data / Medical devices / United States / Carlsmed, Inc.
Carlsmed, Inc.: FDA-registered device maker in Carlsbad, CA, United States, 22 510(k) clearances
Carlsmed, Inc. is registered with the FDA (registration 3017936978) in Carlsbad, CA, United States. It lists 11 device types. The FDA files 22 510(k) clearances under its listings, the newest dated September 24, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3017936978
- Address
- 1800 Aston Avenue Suite 100, Carlsbad, CA, United States, 92008
- Owner or operator
- Carlsmed, Inc. (10080208)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- January 19, 2021
- Registered through
- 2026
- Brand names listed
- aprevo anterior lumbar fusion device with interfixation, aprevo® Awls, aprevo® Cervical Interbody System, aprevo® Digital Planning, aprevo® Digital Segmentation, aprevo® Digital Workflow, aprevo® Inserter, aprevo® TLIF-C Articulating System and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 24, 2026 | K262149 | corra® cervical plating system | KWQ | Substantially Equivalent | Carlsmed, Inc. | accessdata.fda.gov |
| April 22, 2026 | K260570 | corra cervical plating system | KWQ | Substantially Equivalent | Carlsmed, Inc. | accessdata.fda.gov |
| January 6, 2026 | K252894 | aprevo® cervical interbody system | ODP | Substantially Equivalent | Carlsmed, Inc. | accessdata.fda.gov |
| December 22, 2025 | K252611 | aprevo® cervical plating system | KWQ | Substantially Equivalent | Carlsmed, Inc. | accessdata.fda.gov |
| July 7, 2025 | 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 | Substantially Equivalent | Carlsmed, Inc. | accessdata.fda.gov |
| June 30, 2025 | K250987 | aprevo® posterior/transforaminal lumbar interbody fusion device | MAX | Substantially Equivalent | Carlsmed, Inc. | accessdata.fda.gov |
| March 17, 2025 | K243802 | aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar interbody fusion device with interfixation | OVD | Substantially Equivalent | Carlsmed, Inc. | accessdata.fda.gov |
| December 20, 2024 | K242599 | aprevo® Digital Planning | LLZ | Substantially Equivalent | Carlsmed, Inc. | accessdata.fda.gov |
| December 13, 2024 | K243635 | aprevo® anterior lumbar interbody fusion device with interfixation | OVD | Substantially Equivalent | Carlsmed, Inc. | accessdata.fda.gov |
| November 15, 2024 | K242260 | aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAM | ODP | Substantially Equivalent | Carlsmed, Inc. | accessdata.fda.gov |
| October 9, 2024 | K241477 | aprevo® anterior lumbar interbody fusion device with interfixation | OVD | Substantially Equivalent | Carlsmed, Inc. | accessdata.fda.gov |
| September 20, 2024 | K241332 | aprevo® anterior and lateral lumbar interbody fusion device; aprevo® anterior lumbar interbody fusion devices with interfixation; aprevo® transforaminal lumbar interbody fusion device | MAX | Substantially Equivalent | Carlsmed, Inc. | accessdata.fda.gov |
| August 12, 2024 | 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 | Substantially Equivalent | Carlsmed, Inc. | accessdata.fda.gov |
| July 9, 2024 | K241019 | aprevo® TLIF-C Articulating System | MAX | Substantially Equivalent | Carlsmed | accessdata.fda.gov |
| March 22, 2024 | K232282 | aprevo® anterior and lateral lumbar interbody fusion device, aprevo® transforaminal lumbar interbody fusion device | MAX | Substantially Equivalent | Carlsmed, Inc. | accessdata.fda.gov |
| November 3, 2023 | K231955 | aprevo® Digital Segmentation | QIH | Substantially Equivalent | Carlsmed, Inc. | accessdata.fda.gov |
| May 19, 2023 | K231140 | aprevo® transforaminal lumbar interbody fusion device | MAX | Substantially Equivalent | Carlsmed, Inc. | accessdata.fda.gov |
| December 30, 2022 | K222195 | aprevo® Digital Workflow | LLZ | Substantially Equivalent | Carlsmed, Inc. | accessdata.fda.gov |
| November 22, 2022 | K222009 | aprevo® anterior lumbar interbody fusion device with interfixation | OVD | Substantially Equivalent | Carlsmed, Inc. | accessdata.fda.gov |
| August 12, 2022 | K222082 | aprevo® anterior and lateral lumbar interbody fusion devices, aprevo® transforaminal lumbar interbody fusion devices | MAX | Substantially Equivalent | Carlsmed, Inc. | accessdata.fda.gov |
| June 30, 2021 | K210542 | aprevo Transforaminal IBF | MAX | Substantially Equivalent | Carlsmed, Inc. | accessdata.fda.gov |
| December 3, 2020 | K202034 | aprevo Intervertebral Body Fusion Device | MAX | Substantially Equivalent | Carlsmed, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Appliance, Fixation, Spinal Intervertebral Body
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- All makers of Intervertebral Fusion Device With Bone Graft, Lumbar
- All makers of Intervertebral Fusion Device With Integrated Fixation, Lumbar
- All makers of Automated Radiological Image Processing Software
Updated September 24, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.