Class Class II
Solar™ Lumbar Interbody Fusion System (K240326)
Description
Solar™ Lumbar Interbody Fusion System by Degen Medical, Inc., an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK240326
Clearance Date2024-07-29
Clearance TypeTraditional
Product CodeMAX
Regulation Number888.3080
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K240326
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. Solar™ Lumbar Interbody Fusion System (K240326) cites 2 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K231199 | Solar Lumbar Interbody Fusion System | Degen Medical | 2023 |
| K213935 | PISCES-SA Standalone ALIF Interbody System | Osseus Fusion Systems | 2022 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K241077 | DeGen Medical Patient Specific Implant (PSI) System | Degen Medical | 2024 |
Trace the full predicate network for K240326
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.