aprevo® anterior and lateral lumbar interbody fusion device; aprevo® anterior lumbar interbody fusion devices with interfixation; aprevo® transforaminal lumbar interbody fusion device (K241332)
Description
aprevo® anterior and lateral lumbar interbody fusion device; aprevo® anterior lumbar interbody fusion devices with interfixation; aprevo® transforaminal lumbar interbody fusion device by Carlsmed, Inc., an FDA 510(k) cleared orthopedic device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K241332
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. aprevo® anterior and lateral lumbar interbody fusion device; aprevo® anterior lumbar interbody fusion devices with interfixation; aprevo® transforaminal lumbar interbody fusion device (K241332) cites 3 predicate devices and is itself cited by 3 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K231140 | aprevo® transforaminal lumbar interbody fusion device | Carlsmed, Inc. | 2023 |
| K222009 | aprevo® anterior lumbar interbody fusion device with interf... | Carlsmed, Inc. | 2022 |
| K222082 | aprevo® anterior and lateral lumbar interbody fusion device... | Carlsmed, Inc. | 2022 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K250827 | aprevo® anterior lumbar interbody fusion device; aprevo® la... | Carlsmed, Inc. | 2025 |
| K250987 | aprevo® posterior/transforaminal lumbar interbody fusion de... | Carlsmed, Inc. | 2025 |
| K243802 | aprevo® anterior and lateral lumbar interbody fusion device... | Carlsmed, Inc. | 2025 |
Trace the full predicate network for K241332
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.