Carlsmed, Inc.
Carlsbad, CA, US
CARLSMED, INC. appears in FDA device records in Carlsbad, CA. FDA records list 22 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 22 510(k) clearances for Carlsmed, Inc. between 2020 and 2026. The busiest year on record is 2024, with 8. The most recent is 2026, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2020 | 1 |
| 2021 | 1 |
| 2022 | 3 |
| 2023 | 2 |
| 2024 | 8 |
| 2025 | 4 |
| 2026 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K260385 | aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and transforaminal lumbar interbody system; aprevo® cervical interbody system; corra™ cervical plating system | MAX | Substantially Equivalent | |
| K260570 | corra™ cervical plating system | KWQ | Substantially Equivalent | |
| K252894 | aprevo® cervical interbody system | ODP | Substantially Equivalent | |
| K252611 | aprevo® cervical plating system | KWQ | Substantially Equivalent | |
| 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 | |
| K250987 | aprevo® posterior/transforaminal lumbar interbody fusion device | MAX | Substantially Equivalent | |
| K243802 | aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar interbody fusion device with interfixation | OVD | Substantially Equivalent | |
| K242599 | aprevo® Digital Planning | LLZ | Substantially Equivalent | |
| K243635 | aprevo® anterior lumbar interbody fusion device with interfixation | OVD | Substantially Equivalent | |
| K242260 | aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAM | ODP | Substantially Equivalent | |
| K241477 | aprevo® anterior lumbar interbody fusion device with interfixation | OVD | Substantially Equivalent | |
| 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 | |
| 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 | |
| K241019 | aprevo® TLIF-C Articulating System | MAX | Substantially Equivalent | |
| K232282 | aprevo® anterior and lateral lumbar interbody fusion device, aprevo® transforaminal lumbar interbody fusion device | MAX | Substantially Equivalent | |
| K231955 | aprevo® Digital Segmentation | QIH | Substantially Equivalent | |
| K231140 | aprevo® transforaminal lumbar interbody fusion device | MAX | Substantially Equivalent | |
| K222195 | aprevo® Digital Workflow | LLZ | Substantially Equivalent | |
| K222009 | aprevo® anterior lumbar interbody fusion device with interfixation | OVD | Substantially Equivalent | |
| K222082 | aprevo® anterior and lateral lumbar interbody fusion devices, aprevo® transforaminal lumbar interbody fusion devices | MAX | Substantially Equivalent | |
| K210542 | aprevo Transforaminal IBF | MAX | Substantially Equivalent | |
| K202034 | aprevo Intervertebral Body Fusion Device | MAX | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3017936978 | 3017936978 | CARLSMED, INC. | 1800 Aston Avenue, Carlsbad, CA 92008 US | 2026 | and 1 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KWQAppliance, Fixation, Spinal Intervertebral Body
- QIHAutomated Radiological Image Processing Software
- HWJAwl
- HTWBit, Drill
- FZXGuide, Surgical, Instrument
- ODPIntervertebral Fusion Device With Bone Graft, Cervical
- MAXIntervertebral Fusion Device With Bone Graft, Lumbar
- OVEIntervertebral Fusion Device With Integrated Fixation, Cervical
- OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar
- LXHOrthopedic Manual Surgical Instrument
- LLZSystem, Image Processing, Radiological
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain